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1.
BMC Pediatr ; 24(1): 187, 2024 Mar 16.
Artigo em Inglês | MEDLINE | ID: mdl-38493088

RESUMO

BACKGROUND: Preterm birth (birth before 37 completed weeks of pregnancy) is the leading cause of neonatal and child under-five mortality globally, both of which are highest regionally in sub-Saharan Africa. The skin barrier plays a critical role in neonatal health and increasing evidence supports the use of topical emollient therapy to promote postnatal growth and reduce hospital-acquired infections in preterm infants. The World Health Organization (WHO) currently recommends emollient therapy in preterm or low birthweight infants globally but calls for further research on impacts of emollient use, especially in Africa. Little is known about postnatal skincare practices and the tradition of oil massage across sub-Saharan Africa. Further documentation is necessary to understand the context for future emollient intervention trials. METHODS: 61 semi-structured interviews with mothers who just delivered preterm or term infants and 4 focus group discussions (32 participants) with physician and nurse providers of newborn care were conducted at Sally Mugabe Central Hospital (SMCH), in Harare, Zimbabwe. SMCH is the principal public-sector tertiary care hospital for newborn infants in the northern part of the country. Mothers and healthcare professionals were questioned about newborn care at the hospital, current neonatal skincare and bathing practices, and the community's receptivity to a future emollient therapy clinical trial. RESULTS: Postnatal skincare is centrally important to Zimbabwean communities and petroleum jelly application is nearly universal. The use of cooking oil and other natural oils on infants is also part of traditional customs. The primary needs and desires of mothers who have just given birth to preterm infants are having greater agency in their children's care and financial support in purchasing prescribed medications while at the hospital. Community receptivity to emollient therapy as a cost-effective treatment is high, particularly if mothers are trained to assist with the intervention. CONCLUSION: Emollient therapy will likely be well-received by communities in and around Harare because of its accordance with current skincare practices and perceptions; however, cultural norms and the experiences of new mothers who have given birth at a facility highlight challenges and considerations for future clinical trial execution. TRIAL REGISTRATION: Clinicaltrials.gov NCT05461404.


Assuntos
Recém-Nascido Prematuro , Nascimento Prematuro , Feminino , Humanos , Recém-Nascido , Emolientes/uso terapêutico , Recém-Nascido de muito Baixo Peso , Cuidado Pós-Natal , Zimbábue
2.
J Drugs Dermatol ; 23(3): 192-194, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38443116

RESUMO

Plaque psoriasis is a chronic, immune-mediated, cutaneous, and systemic inflammatory dermatosis. Its pathogenesis involves the dysregulation of the interleukin (IL)-23/IL-17 signaling pathway. There are a range of treatment options available, encompassing topical agents, biologics, oral systemic therapy, and phototherapy. The utility of combination treatment has also been described and is a budding field of research. Here we describe the first case of adult severe generalized plaque psoriasis treated with once-daily oral deucravacitinib 6 mg combined with tapinarof cream 1% applied once daily. To our knowledge, the combination of these agents has not yet been described in the literature. J Drugs Dermatol. 2024;23(3):     doi:10.36849/JDD.8091.


Assuntos
Compostos Heterocíclicos , Psoríase , Estilbenos , Adulto , Humanos , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Terapia Combinada , Resorcinóis , Emolientes
3.
Dermatitis ; 35(S1): S62-S69, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38394048

RESUMO

Background: Preliminary studies support the use of topical coconut and sunflower seed oil for atopic dermatitis (AD). However, standardized topical formulations of fatty acids from these sources have not been studied. Objective: This study investigates whether coconut oil- and sunflower seed oil-derived isosorbide diesters can be used in conjunction with colloidal oatmeal to improve itch, AD severity, and the need for topical steroids in adults. Methods: This was a single-center, 4-week, randomized, double-blind, and vehicle-controlled study conducted between 2021 and 2022. Thirty-two male and female adults with mild-to-moderate AD were enrolled and completed the study. Participants were randomized to receive either 0.1% colloidal oatmeal (vehicle) or isosorbide diesters (IDEAS, 4% isosorbide dicaprylate and 4% isosorbide disunflowerseedate) along with 0.1% colloidal oatmeal. The main outcomes of the study were changes in the visual analogue rating of itch and 75% improvement in the Eczema Area and Severity Index score (EASI 75) at 4 weeks. Other measures included the use of topical steroids and the relative abundance of skin Staphylococcus aureus. Results: Participants in the IDEAS group had a 65.6% improvement in itch compared with 43.8% in the vehicle group (P = 0.013). In total, 56.5% and 25% of the those in the IDEAS and vehicle groups, respectively, achieved EASI 75 at 4 weeks (P = 0.07). There was no difference in skin hydration or transepidermal water loss. The relative abundance of S. aureus was decreased in the IDEAS group at week 4 compared with no change in the vehicle group (P = 0.044). Topical corticosteroid use increased in the vehicle group compared with a decrease in the IDEAS group at week 1 (292.5% vs 24.8%; P value = 0.039) and week 2 (220% vs 46%; P value = 0.08). Conclusions: Topical application of emollients containing coconut oil- and sunflower seed oil-derived fatty esters may improve itch, reduce topical steroid use, and reduce the relative abundance of S. aureus in mild-to-moderate AD. CTR number: NCT04831892.


Assuntos
Dermatite Atópica , Adulto , Humanos , Masculino , Feminino , Dermatite Atópica/tratamento farmacológico , Óleo de Girassol , Óleo de Coco , Staphylococcus aureus , Cocos , Estudos Prospectivos , Resultado do Tratamento , Prurido/tratamento farmacológico , Emolientes , Método Duplo-Cego , Índice de Gravidade de Doença , Esteroides
4.
Int J Pharm ; 653: 123825, 2024 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-38253270

RESUMO

The targeted choice of the emollient of a cream determines its physicochemical properties and clinical effectiveness. This work researched the effects of emollient properties on the final characteristics and potential performance of oil-in-water dermatological creams. Seven emollients with different chemical characteristics and structures (alkane, triglyceride, ether, silicone, vegetable oils, and mineral oil) were tested in a model formulation. Early stability, pH, droplet size distribution, rheology, tackiness, adhesivity, spreadability, tribology, and release profile of a lipophilic substance model (in Franz cells, through a synthetic membrane, for six hours) were assessed. The creams had acid epicutaneous pH and a "shear-thinning" "solid-like" viscoelastic behavior. Among the seven emollients' properties, polarity, density, and viscosity were the most influential. Droplet parameters were the most impacted, pH and release were moderately affected, and the textural properties were lowly to moderately impacted. The emollient substitution in the model formulation affected the experimental parameters differently, allowing formulation optimization and tailoring its potential therapeutic performance regarding drug release, coadjutant effects, and dwell time on the skin. By looking at the creams' characteristics, it was possible to select the best-suited emollients for releasing a lipophilic drug, applying on painful skin, and formulation in wash-off products or leave-on protective barrier creams.


Assuntos
Emolientes , Óleo Mineral , Emolientes/química , Óleos de Plantas/química , Pele , Reologia
5.
BMC Complement Med Ther ; 24(1): 61, 2024 Jan 29.
Artigo em Inglês | MEDLINE | ID: mdl-38287323

RESUMO

BACKGROUND: Eczema is a chronic, relapsing skin condition commonly managed by emollients and topical corticosteroids. Prevalence of use and demand for effective botanical therapies for eczema is high worldwide, however, clinical evidence of benefit is limited for many currently available botanical treatment options. Robustly-designed and adequately powered randomised controlled trials (RCTs) are essential to determine evidence of clinical benefit. This protocol describes an RCT that aims to investigate whether a manuka oil based emollient cream, containing 2% ECMT-154, is a safe and effective topical treatment for moderate to severe eczema. METHODS: This multicentre, single-blind, parallel-group, randomised controlled trial aims to recruit 118 participants from community pharmacies in Aotearoa New Zealand. Participants will be randomised 1:1 to receive topical cream with 2% ECMT-154 or vehicle control, and will apply assigned treatment twice daily to affected areas for six weeks. The primary outcome is improvement in subjective symptoms, assessed by change in POEM score. Secondary outcomes include change in objective symptoms assessed by SCORAD (part B), PO-SCORAD, DLQI, and treatment acceptability assessed by TSQM II and NRS. DISCUSSION: Recruitment through community pharmacies commenced in January 2022 and follow up will be completed by mid-2023. This study aims to collect acceptability and efficacy data of manuka oil based ECMT-154 for the treatment of eczema. If efficacy is demonstrated, this topical may provide an option for a novel emollient treatment. The community-based design of the trial is anticipated to provide a generalisable result. ETHICS AND DISSEMINATION: Ethics approval was obtained from Central Health and Disability Ethics Committee (reference: 2021 EXP 11490). Findings of the study will be disseminated to study participants, published in peer-reviewed journal and presented at scientific conferences. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621001096842. Registered on August 18, 2021 ( https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382412&isReview=true ). PROTOCOL VERSION: 2.1 (Dated 18/05/2022).


Assuntos
Eczema , Farmácias , Humanos , Emolientes/uso terapêutico , Nova Zelândia , Índice de Gravidade de Doença , Austrália , Eczema/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
6.
Int Health ; 16(2): 152-164, 2024 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-37480339

RESUMO

There have been few reports from Africa on the use and health effects of emollient therapy for newborn infants. We aimed to describe neonatal skin care practices in Africa, and to illuminate opportunities to introduce evidence-based interventions to improve these practices. We conducted a scoping review of the quantitative and qualitative published peer-reviewed and grey literature in English on emollient use in Africa. Outcomes of interest included neonatal skin care practices, with a focus on the application of oils and other products to infant skin, including in association with bathing and massage. We screened 5257 articles and summarised findings from 23 studies-13 qualitative, nine quantitative and one mixed methods-that met our study criteria. Seven studies reported the use of emollients for perceived benefits, including thermal care, treatment for illness, promotion of growth and development, infection reduction, skin condition improvement, spirituality and lubrication to aid massage. Four studies reported the quantitative health impact of skin care product applications, including improvements in skin condition, neurodevelopment and bone growth, as well as a reduction in nosocomial infections. This review highlights opportunities for skin care intervention and future research on neonatal skin care practices in Africa.


Assuntos
Emolientes , Massagem , Lactente , Recém-Nascido , Humanos , Emolientes/uso terapêutico , África
7.
J Cosmet Dermatol ; 23(3): 1045-1054, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38050657

RESUMO

OBJECTIVE: The current study aimed to provide preliminary insights into potential biopharmaceutical applications of Carica papaya seed extract by evaluating its phytochemical and biological profiles. Furthermore, the study aimed to develop a stable oil-in-water (O/W) emulsion for the effective delivery of antioxidant-rich biologicals for cosmetic purposes. METHODS: The hydroethanolic (ethanol 80%: 20% water) extract of C. papaya seeds was prepared via maceration technique. The chemical composition was carried out through preliminary phytochemical screening and estimation of total phenolic contents (TPC) and total flavonoid contents (TFC). The biological profile of the extract was explored using various in-vitro antioxidant methods. The homogenization procedure was used to create a cream of O/W and various tests were applied to assess the stability of the emulsion. By keeping the emulsion at different storage conditions (8 ± 0.5°C, 25 ± 0.5°C, 40 ± 0.5°C, and 40 ± 0.5°C ± 75% relative humidity [RH]) for a period of 28 days), the physical stability parameters of the emulsion, including pH, viscosity, centrifugation, phase separation, and conductivity, as well as rheological parameters and organoleptic parameters (odor, color, liquefaction, and creaming), were assessed. RESULTS: The preliminary phytochemical screening assay revealed the presence of various plant secondary metabolites including alkaloids, phenolics, flavonoids, tannins, saponins, and quinones. The extract was found to be rich in TPC and TFC. The in vitro antioxidant study gave maximum activity in the DPPH method. The plant extract containing cosmetic cream exhibited remarkable stability during the entire research. Data gathered indicated that no phase separation or liquefaction was seen after the experimental period. Throughout the experimental period, a small variation in the pH and conductivity values of the base and formulation was seen. CONCLUSION: The findings suggest that the seed extract of C. papaya is a rich source of polyphenols with antioxidant potential and can be a promising alternative for the treatment of various ailments. The stability of emulsion paves the way for its utilization as a carrier for the delivery of 3% C. papaya seed extract and applications in cosmetics products.


Assuntos
Produtos Biológicos , Carica , Humanos , Antioxidantes , Emulsões , Emolientes , Flavonoides , Compostos Fitoquímicos , Extratos Vegetais/farmacologia , Água
8.
J Cosmet Dermatol ; 23(3): 911-917, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37927123

RESUMO

INTRODUCTION: Infraorbital hyperpigmentation represents one of the most prevalent conditions in cosmetic dermatology. To treat this condition, many patients prefer natural remedies. This study explored the efficacy of topical castor oil cream in treating patients with infraorbital hyperpigmentation. METHODS: We conducted an exploratory single-arm clinical trial at the Shahid Faghihi Dermatology Clinic and Molecular Dermatology Research Center of Shiraz University of Medical Sciences, Shiraz, Iran, during 2021-2022. Using the convenience sampling method, we enrolled 25 patients with infraorbital hyperpigmentation. We instructed the patients to apply topical castor oil cream twice daily for 2 months. The darkness, melanin, and erythema levels were evaluated by VisioFace® 1000 D and SkinColorCatch® devices. We used a visual analog scale to assess skin laxity, wrinkles, and patient satisfaction. Data analysis was done with Stata version 14.2. RESULTS: The data of 22 patients with a mean age of 40.92 ± 7.33 years were analyzed. The VisioFace® scores decreased significantly by the end of the study [right eyes: mean difference (MD): -5.63 (95% CI: -7.12 to -4.15), p < 0.001; left eyes: MD: -5.91 (95% CI: -7.46 to -4.36), p < 0.001]. Moreover, castor oil cream significantly reduced the melanin level, wrinkles, and skin laxity in the infraorbital region (p < 0.05). CONCLUSIONS: Castor oil cream seems to be an effective alternative for treating infraorbital hyperpigmentation. Randomized clinical trials are needed to confirm our findings.


Assuntos
Óleo de Rícino , Hiperpigmentação , Adulto , Humanos , Pessoa de Meia-Idade , Óleo de Rícino/uso terapêutico , Cosméticos/uso terapêutico , Emolientes/uso terapêutico , Hiperpigmentação/tratamento farmacológico , Melaninas , Creme para a Pele , Resultado do Tratamento
9.
J Cutan Med Surg ; 28(1): 22-28, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-37942562

RESUMO

BACKGROUND: Acne vulgaris is a common dermatological condition that greatly impacts patients' self-confidence. Ongoing research is conducted to explore new treatment modalities. Silymarin owns special characteristics that qualify it as a possible treatment for acne vulgaris. OBJECTIVE: We evaluated the efficacy and safety of silymarin cream as a new therapeutic option against salicylic acid peels in the treatment of mild to moderate acne vulgaris. METHODS: A split-face, comparative, Quasi-experimental clinical trial included 30 patients with acne vulgaris. Salicylic acid 30% peels were applied as an office procedure to one half of the face every 2 weeks for 3 months. Topical silymarin 1.4% cream was prescribed as a home treatment, twice daily, to the other half of the face for 3 months. The results were evaluated using the Global Acne Grading System (GAGS), photographic evaluation, and patient self-assessment scale. The adverse effects during treatment were recorded. The sample size was calculated by Stata/IC 16.1. RESULTS: After treatment, a significant reduction of GAGS was noted on both sides of the face, with an insignificant difference between both treatments. The comparative photographic evaluation and patient self-assessment scale were also insignificant. Hyperpigmentation was recorded in 2 cases on the salicylic acid-treated side. No side effects for silymarin cream were observed. CONCLUSION: Topical silymarin cream 1.4% showed comparable results to Salicylic acid 30% peels. It can be considered a promising safe treatment modality for mild to moderate acne vulgaris.


Assuntos
Acne Vulgar , Ácido Salicílico , Silimarina , Humanos , Acne Vulgar/tratamento farmacológico , Emolientes , Hiperpigmentação , Ácido Salicílico/efeitos adversos , Silimarina/efeitos adversos
10.
Health Technol Assess ; 27(19): 1-120, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37924282

RESUMO

Background: Emollients are recommended for children with eczema (atopic eczema/dermatitis). A lack of head-to-head comparisons of the effectiveness and acceptability of the different types of emollients has resulted in a 'trial and error' approach to prescribing. Objective: To compare the effectiveness and acceptability of four commonly used types of emollients for the treatment of childhood eczema. Design: Four group, parallel, individually randomised, superiority randomised clinical trials with a nested qualitative study, completed in 2021. A purposeful sample of parents/children was interviewed at ≈ 4 and ≈ 16 weeks. Setting: Primary care (78 general practitioner surgeries) in England. Participants: Children aged between 6 months and 12 years with eczema, of at least mild severity, and with no known sensitivity to the study emollients or their constituents. Interventions: Study emollients sharing the same characteristics in the four types of lotion, cream, gel or ointment, alongside usual care, and allocated using a web-based randomisation system. Participants were unmasked and the researcher assessing the Eczema Area Severity Index scores was masked. Main outcome measures: The primary outcome was Patient-Oriented Eczema Measure scores over 16 weeks. The secondary outcomes were Patient-Oriented Eczema Measure scores over 52 weeks, Eczema Area Severity Index score at 16 weeks, quality of life (Atopic Dermatitis Quality of Life, Child Health Utility-9 Dimensions and EuroQol-5 Dimensions, five-level version, scores), Dermatitis Family Impact and satisfaction levels at 16 weeks. Results: A total of 550 children were randomised to receive lotion (analysed for primary outcome 131/allocated 137), cream (137/140), gel (130/135) or ointment (126/138). At baseline, 86.0% of participants were white and 46.4% were female. The median (interquartile range) age was 4 (2-8) years and the median Patient-Oriented Eczema Measure score was 9.3 (SD 5.5). There was no evidence of a difference in mean Patient-Oriented Eczema Measure scores over the first 16 weeks between emollient types (global p = 0.765): adjusted Patient-Oriented Eczema Measure pairwise differences - cream-lotion 0.42 (95% confidence interval -0.48 to 1.32), gel-lotion 0.17 (95% confidence interval -0.75 to 1.09), ointment-lotion -0.01 (95% confidence interval -0.93 to 0.91), gel-cream -0.25 (95% confidence interval -1.15 to 0.65), ointment-cream -0.43 (95% confidence interval -1.34 to 0.48) and ointment-gel -0.18 (95% confidence interval -1.11 to 0.75). There was no effect modification by parent expectation, age, disease severity or the application of UK diagnostic criteria, and no differences between groups in any of the secondary outcomes. Median weekly use of allocated emollient, non-allocated emollient and topical corticosteroids was similar across groups. Overall satisfaction was highest for lotions and gels. There was no difference in the number of adverse reactions and there were no significant adverse events. In the nested qualitative study (n = 44 parents, n = 25 children), opinions about the acceptability of creams and ointments varied most, yet problems with all types were reported. Effectiveness may be favoured over acceptability. Parents preferred pumps and bottles over tubs and reported improved knowledge about, and use of, emollients as a result of taking part in the trial. Limitations: Parents and clinicians were unmasked to allocation. The findings may not apply to non-study emollients of the same type or to children from more ethnically diverse backgrounds. Conclusions: The four emollient types were equally effective. Satisfaction with the same emollient types varies, with different parents/children favouring different ones. Users need to be able to choose from a range of emollient types to find one that suits them. Future work: Future work could focus on how best to support shared decision-making of different emollient types and evaluations of other paraffin-based, non-paraffin and 'novel' emollients. Trial registration: This trial is registered as ISRCTN84540529 and EudraCT 2017-000688-34. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (HTA 15/130/07) and will be published in full in Health Technology Assessment; Vol. 27, No. 19. See the NIHR Journals Library website for further project information.


One in five children in the UK have eczema, a long-term, itchy, dry skin condition. It can significantly affect both the child and their family. Most children are diagnosed and looked after by their family doctor (general practitioner) and are prescribed moisturisers (also called emollients) to relieve skin dryness and other creams (topical corticosteroids) to control flare-ups. However, there are many different types of emollients and, to our knowledge, limited research to show which is better. In the Best Emollients for Eczema clinical trial, we compared the four main types of moisturisers ­ lotions, creams, gels and ointments. These types vary in their consistency, from thin to thick. We recruited 550 children (most of whom were white and had moderate eczema) and randomly assigned them to use one of the four different types as their main moisturiser for 16 weeks. We found no difference in effectiveness. Parent-reported eczema symptoms, eczema severity and quality of life were the same for all the four types of moisturisers. However, overall satisfaction was highest for lotions and gels. Ointments may need to be used less and cause less stinging. We interviewed 44 parents and 25 children who took part. Opinions of all four types of moisturisers varied. What one family liked about a moisturiser was not necessarily the same for another and preferences were individual to each user. Sometimes there was a tension between how well a moisturiser worked (effectiveness) and how easy it was to use (acceptability). In these cases, effectiveness tended to decide whether or not parents kept using it. People found moisturisers in pumps and bottles easier to use than those in tubs. A number of participants valued the information they were given about how to use moisturisers. Our results suggest that the type of moisturiser matters less than finding one that suits the child and family.


Assuntos
Dermatite Atópica , Eczema , Criança , Feminino , Humanos , Masculino , Análise Custo-Benefício , Dermatite Atópica/induzido quimicamente , Dermatite Atópica/tratamento farmacológico , Eczema/tratamento farmacológico , Emolientes , Pomadas/uso terapêutico , Qualidade de Vida , Índice de Gravidade de Doença , Pré-Escolar
11.
J Eur Acad Dermatol Venereol ; 37(12): 2601-2607, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37620285

RESUMO

BACKGROUND: Kligman's trio (KT), combining hydroquinone, retinoic acid and corticosteroid, is considered as the gold standard treatment of melasma. Its efficacy has never been matched before, but it is tempered by frequent adverse effects. OBJECTIVE: To assess the efficacy and tolerance of a New Trio (NT) combination with isobutylamido-thiazolyl-resorcinol, retinoic acid and cortosteroid compared to KT. METHODS: We conducted a 24-week monocentric trial, randomized, double-blind, controlled versus KT, with 40 melasma patients. NT and KT were applied for 12 weeks and associated with the same sunscreen applied for 24 weeks. The primary endpoint was the modified Melasma Area Severity Index (mMASI) at 12 weeks. Patient quality of life was investigated using MelasQoL. RESULTS: After 12 weeks, KT and NT groups both demonstrated a significant improvement in mMASI, respectively -2.84 (SE 0.69, p < 0.0002) and -4.33 (SE 0.71, p < 0.0001). The mean difference between the two groups was -1.49 (IC 95% -3.52 to 0.54, p = 0.14). MelasQoL improvement was -6.66 (SE 3.29, p = 0.0515) with KT and -12.57 (SE 3.29, p = 0.0006) with NT. CONCLUSION: The NT combination appears to be an effective treatment option for treating melasma and could be considered as a well-tolerated alternative to KT.


Assuntos
Melanose , Qualidade de Vida , Humanos , Estudos Prospectivos , Tretinoína/efeitos adversos , Resultado do Tratamento , Emolientes , Melanose/tratamento farmacológico , Hidroquinonas/efeitos adversos
12.
J Eur Acad Dermatol Venereol ; 37(11): 2327-2335, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37432045

RESUMO

BACKGROUND: The fixed dose combination of calcipotriene (CAL) and betamethasone dipropionate (BDP) is a well-established topical treatment option for psoriasis based on strong scientific rationale for the single agents having complementary efficacy and safety. CAL/BDP PAD-cream is an easily spreadable cream based on PAD Technology™, an innovative formulation and drug delivery system. OBJECTIVES AND METHODS: A Phase 3, multicentre, randomized, investigator-blind, active and vehicle-controlled trial enrolling 490 patients with mild to moderate psoriasis according to the Physician Global Assessment (PGA) scale was conducted in three European countries. Products were applied once daily for 8 weeks. The aim of the trial was to evaluate the efficacy and safety of CAL/BDP PAD-cream as well as treatment acceptability compared to CAL/BDP gel and PAD-cream vehicle. Primary endpoint was percentage change in modified Psoriasis Area and Severity Index (mPASI) from baseline to Week 8. RESULTS: The percentage mean change from baseline to Week 8 in mPASI for CAL/BDP PAD-cream (67.5%) was superior compared to PAD-cream vehicle (11.7%; p < 0.0001) and non-inferior to CAL/BDP gel (63.5%). The proportion of patients achieving PGA treatment success (at least two-step improvement to clear or almost clear) after 8 weeks was superior for CAL/BDP PAD-cream (50.7%) compared to PAD-cream vehicle (6.1%, p < 0.0001) and statistically significantly greater than CAL/BDP gel (42.7%, p = 0.0442). Patient-reported psoriasis treatment convenience score (PTCS) for CAL/BDP PAD-cream was rated superior to CAL/BDP gel at Week 8 (p < 0.0001) and the mean change in DLQI from baseline to Week 8 improved statistically significantly more in the CAL/BDP PAD-cream group compared to both PAD-cream vehicle (p < 0.0001) and CAL/BDP gel (p = 0.0110). Safety assessments during the trial demonstrated that CAL/BDP PAD-cream was well-tolerated. CONCLUSION: CAL/BDP PAD-cream is a novel topical treatment of psoriasis that has a high efficacy and a favourable safety profile combined with a superior patient-reported treatment convenience.


Assuntos
Fármacos Dermatológicos , Psoríase , Humanos , Combinação de Medicamentos , Psoríase/tratamento farmacológico , Psoríase/induzido quimicamente , Calcitriol/efeitos adversos , Betametasona/efeitos adversos , Resultado do Tratamento , Emolientes/uso terapêutico , Fármacos Dermatológicos/efeitos adversos
13.
PeerJ ; 11: e15262, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37312874

RESUMO

Potato is one of the most commonly consumed non-grain staple food crops in the world therefore, the mineral nutrient content of the potato is extremely important for human nutrition. The lack of mineral nutrients causes significant health problems, thus, many of these nutrients are often taken as supplements. This study was carried out to investigate the effects of potato flesh color and location on different mineral nutrient contents under Niksar, Kazova and Artova locations in Tokat Province, Turkey, during 2013 and 2014 potato growing seasons. The experimental design in each location was randomized blocks with three replications. In this study, a total of 67 clones (including varieties and advanced breeding selections) with nine white, 10 cream, 30 light yellow, and 18 dark yellow flesh colors were used. Potatoes with cream flesh colors had the highest K (23.81 g kg-1), P (0.31 g kg-1), Mg (1.20 g kg-1), Zn (27.26 mg kg-1), Cu (8.28 mg kg-1) and Mn (7.21 mg kg-1) contents, and the lowest Ca (45.6 mg kg-1) content. The mineral contents (except K and Cu) of potatoes grown in Artova were higher compared to the other two locations. The results clearly suggested that Artova is the most suitable location to produce potatoes with a high mineral composition, and Kazova is suitable to cultivate potatoes with high K and Cu contents. In addition, the knowledge of nutrient rich potato accessions is valuable for developing biofortified potato genotypes.


Assuntos
Solanum tuberosum , Humanos , Solanum tuberosum/genética , Turquia , Cor , Melhoramento Vegetal , Nutrientes , Minerais , Suplementos Nutricionais , Emolientes
14.
Int J Cosmet Sci ; 45(5): 636-646, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37235713

RESUMO

OBJECTIVE: Dark circles in the infraorbital area are a common cosmetic concern among individuals because they exhibit fatigue and are undesirable across all ages. Of the dark circle etiologies, blood stasis by poor-vascular integrity can cause darkening of the lower eyelid skin, which might be alleviated by reduced endothelial permeability. In this study, we investigated the effects of Salix alba bark extract (SABE) on the synthesis of hyaluronic acid (HA) in fibroblasts and vascular integrity protection from inflammatory cytokine. We also performed a clinical trial investigating the effect of SABE on dark circles. METHODS: To confirm the effect of SABE on HA synthesis in human dermal fibroblasts (HDFs), we performed ELISA and real-time PCR. We investigated the interaction HDF-secreted substance with vascular integrity, and human dermal microvascular endothelial cells (HMEC-1) were treated with conditioned medium (CM) from HDF treated with or without SABE. Subsequently, we conducted a clinical study on 29 subjects by having them apply SABE containing cream for 8 weeks. RESULTS: Salix alba bark extract treatment increased HA synthesis and regulated HMW-HA-related gene expressions in HDF. CM from SABE-treated HDF alleviated endothelial permeability and led to improved vascular integrity in HMEC-1 cells. Treatment with the cream containing 2% SABE for 8 weeks improved the parameters measuring dark circles, skin microcirculation and elasticity. CONCLUSION: Our results showed that SABE could protect against dark circles in vitro, and that topical treatment of SABE improved the clinical indexes of dark circles in a clinical study. Therefore, SABE can be used as an active ingredient for improving dark circles.


OBJECTIF: Les cernes dans la région infra-orbitaire sont un problème cosmétique fréquent chez les patients, car elles témoignent de la fatigue et sont indésirables à tout âge. Parmi les étiologies de cerne, la stase sanguine due à une mauvaise intégrité vasculaire peut entraîner un assombrissement de la peau de la paupière inférieure qui peut être atténué par une réduction de la perméabilité endothéliale. Dans cette étude, nous avons étudié les effets de l'extrait d'écorce de Salix alba sur la synthèse de l'acide hyaluronique (AH) dans les fibroblastes, et la protection de l'intégrité vasculaire contre les cytokines inflammatoires. Nous avons également réalisé une étude clinique portant sur l'effet de l'extrait d'écorce de Salix alba sur les cernes. MÉTHODES: Pour confirmer l'effet de l'extrait d'écorce de Salix alba sur la synthèse de l'AH dans les fibroblastes dermiques humains (Human Dermal Fibroblasts, HDF), nous avons réalisé un test ELISA et un test PCR en temps réel. Nous avons étudié l'interaction entre la substance sécrétée par les HDF et l'intégrité vasculaire, et les cellules endothéliales microvasculaires dermiques humaines (Human Dermal Microvascular Endothelial Cells, HDMEC-1) ont été traitées avec un milieu conditionné pour les HDF traité avec ou sans extrait d'écorce de Salix alba. Par la suite, nous avons mené une étude clinique auprès de 29 sujets en leur demandant d'appliquer une crème à base d'extrait d'écorce de Salix alba pendant 8 semaines. RÉSULTATS: Le traitement par extrait d'écorce de Salix alba a augmenté la synthèse de l'AH et régulé les expressions géniques liées à l'acide hyaluronique à haut poids moléculaire dans les HDF. Les milieux conditionnés pour les HDF traités par extrait d'écorce de Salix alba ont atténué la perméabilité endothéliale et ont permis une amélioration de l'intégrité vasculaire des cellules HMEC-1. Le traitement avec la crème contenant 2% d'extrait d'écorce de Salix alba pendant 8 semaines a amélioré les paramètres de mesure des cernes, la microcirculation cutanée et l'élasticité. CONCLUSION: Nos résultats ont montré que l'extrait d'écorce de Salix alba pouvait protéger contre les cernes in vitro, et que le traitement topique par extrait d'écorce de Salix alba améliorait les indices cliniques des cernes dans une étude clinique. L'extrait d'écorce de Salix alba peut donc être utilisé comme principe actif pour améliorer les cernes.


Assuntos
Salix , Humanos , Casca de Planta , Células Endoteliais , Pele , Emolientes , Extratos Vegetais/farmacologia , Extratos Vegetais/uso terapêutico
15.
Prim Care ; 50(2): 191-203, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37105601

RESUMO

Atopic dermatitis (AD) is a common, chronic relapsing, and remitting inflammatory skin disease that is characterized by erythematous, scaly, and pruritic lesions often located over the flexural surfaces. Treatment goals of AD include the reduction of itching and burning, as well as the reduction of skin changes. Treatment of AD includes emollients and skin care, topical therapies including topical corticosteroids and steroid-sparing therapies, systemic therapies, and phototherapy.


Assuntos
Dermatite Atópica , Humanos , Dermatite Atópica/terapia , Dermatite Atópica/tratamento farmacológico , Pele , Emolientes/uso terapêutico , Glucocorticoides/uso terapêutico , Fototerapia
16.
J Drugs Dermatol ; 22(1): 3446174-34461710, 2023 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-36607764

RESUMO

Psoriasis is a complex inflammatory disease, which can be triggered by the interplay among keratinocytes, various immune cells, and even dermal vascular endothelial cells. Understanding of the key players and cytokine/chemokine messengers involved in the initiation and maintenance of psoriasis has significantly evolved and led to numerous systemic biologic therapies targeting those specific components. These therapies, despite their successes, do not ubiquitously affect all pathogenic cellular pathways. They also carry their risks and may be contraindicated in certain patient populations. Therefore, other therapeutics are still necessary. Tazarotene, a decades-old topical retinoid, has been successfully used for treating cutaneous psoriasis. Its retinoid effect via binding to retinoic acid receptors (RAR)/retinoic X receptors (RXR) alters cellular gene expression of numerous pathogenic cells and leads to a long-standing maintenance effect despite discontinuation - a phenomenon known as remittance. Concurrent use of tazarotene with topical corticosteroids results in reduced incidence of treatment-related adverse events. A fixed-combination lotion containing halobetasol propionate (HP) and tazarotene (HP 0.01%/TAZ 0.045%, Duobrii, Ortho Dermatologics) was developed implementing polymeric emulsion technology that demonstrates efficacy in psoriasis while mitigating adverse events associated with each component alone as monotherapy. In this paper, we review the pathogenesis of psoriasis and illuminate the effect of tazarotene and HP on key cellular pathways. In addition, we review the clinical efficacy of fixed-combination HP 0.01%/TAZ 0.045% lotion in psoriasis as well as its long-term treatment maintenance, applicability in skin of color, and beneficial economic impact for patients and healthcare stakeholders. As HP 0.01%/TAZ 0.045% lotion is safe and exhibits excellent efficacy, it should be within the therapeutic toolbox for every psoriasis patient.J Drugs Dermatol. 2023;22:1(Suppl 1):s3-10.


Assuntos
Fármacos Dermatológicos , Ácidos Nicotínicos , Psoríase , Humanos , Administração Cutânea , Fármacos Dermatológicos/efeitos adversos , Fármacos Dermatológicos/uso terapêutico , Combinação de Medicamentos , Emolientes/uso terapêutico , Emulsões/uso terapêutico , Células Endoteliais , Psoríase/tratamento farmacológico , Retinoides/uso terapêutico , Índice de Gravidade de Doença , Creme para a Pele , Resultado do Tratamento
17.
Photodermatol Photoimmunol Photomed ; 39(3): 185-192, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-35906863

RESUMO

PURPOSE: PUVA phototherapy is indicated for various dermatological conditions. Adverse events due to PUVA phototherapy are seen in a sizable number of patients and can result in therapy cessation. This review will focus on PUVA pricks, an adverse event first reported by Tegner in 1979. METHODS: Articles were retrieved from PubMed starting from January 1979 until February 2021 yielding 1228 unique articles. Articles were included when they described individual patient characteristics, and patients were treated with PUVA therapy. RESULTS: After screening, 33 patients were extracted from 9 articles, published between 1979 and 2005. CONCLUSION: PUVA pricks are paroxysmal episodes of burning or prickling pain, akin to peripheral neuropathy of the unmyelinated C-fibers. Increased excitability of TRPV1 and TRPA1 channels while under PUVA therapy might be a contributing factor. Effective topical treatment options for PUVA pricks are capsaicin 8% cream, urea 4%, or petrolatum emollients. Antiepileptics such as phenytoin, clonazepam, and gabapentin are acceptable oral treatment options. A possible role of N-acetylcysteine in the prevention of PUVA pricks is discussed, though further research is required.


Assuntos
Emolientes , Terapia PUVA , Humanos , Terapia PUVA/efeitos adversos , Vaselina
18.
Biomed Res Int ; 2022: 1373160, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36467883

RESUMO

Convolvulus arvensis L. is rich in phenolic compounds and traditionally used to treat wounds, skin ulcer, and inflammation. The current study is aimed at scientifically potentiating its traditional wound healing use. The methanolic extract of C. arvensis stem (CaME) was analyzed for HPLC and GC-MS analyses. The binding modes of active compounds were investigated against protein targets glycogen synthase kinase-3ß (GSK-3ß), transforming growth factor-beta (TGF-ß), c-myc, and ß-catenin by molecular docking followed by molecular dynamic simulations which revealed some conserved mode of binding as reported in crystal structures. The antioxidant potential of CaME was evaluated by in vitro methods such as 2,2-diphenyl-1-picrylhydrazyl (DPPH) radical scavenging, hydrogen peroxide scavenging, and ferric reducing power assays. Ointment formulations of 10 and 20% CaME were applied topically and evaluated for wound healing potency against the excisional wound on the skin of Wistar rats. Gentamycin (0.1%) served as standard therapy. The healing process was observed for 20 days in the form of wound size and epithelialization followed by histopathological evaluation of the wound area. Chemical characterization showed the presence of 7-hexadecenoic acid, 2-hexadecylicosan-1-ol, quercetin, gallic acid, ferulic acid, and other compounds. The plant extract exhibited significant in vitro antioxidant activity. The animals treated with 10% ointment showed moderate healing, whereas the treatment with 20% CaME revealed healing potential comparable to the standard 0.1% gentamycin as coevidenced from histopathological evaluation of skin. The study corroborates promising potential of C. arvensis on the healing of wounds, which possibly will be attributed to its antioxidant activity, fatty acids, quercetin, and gallic and caffeic acids, and binding potential of its phytoconstituents (phenolic acids) with wound healing targets.


Assuntos
Convolvulus , Ratos , Animais , Ratos Wistar , Metanol , Pomadas , Quercetina , Antioxidantes/farmacologia , Glicogênio Sintase Quinase 3 beta , Simulação de Acoplamento Molecular , Cicatrização , Emolientes , Extratos Vegetais/farmacologia , Gentamicinas
19.
J Drugs Dermatol ; 21(12): 1370-1371, 2022 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-36468953

RESUMO

Vitiligo is a complex multifactorial disorder of depigmentation affecting 0.5 to 2% of the world's population without specific gender or racial prevalence.1 Though no treatments are FDA approved to repigment vitiligo, topical medications along with phototherapy alone or in combination remain the mainstay of therapy. While Janus Kinase inhibitors and other agents are in development, current topical options are mainly limited to steroid formulations of various potencies or immunomodulatory steroid-sparing agents such as tacrolimus 0.03% or 0.1%.


Assuntos
Tacrolimo , Vitiligo , Humanos , Tacrolimo/uso terapêutico , Vitiligo/diagnóstico , Vitiligo/tratamento farmacológico , Imunossupressores/uso terapêutico , Fototerapia , Emolientes/uso terapêutico , Esteroides , Resultado do Tratamento
20.
Int J Pharm ; 629: 122364, 2022 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-36343905

RESUMO

Powder feeding is of critical importance for continuous manufacturing (CM) since next to in-process segregation it is the phenomenon primarily responsible for fluctuations in content uniformity and for content deviations in the final drug product. So far, feeding studies have focused on the characterization of specific feeders and the prediction of their performance for various materials. This work presents a more holistic approach, an early general assessment of the "feedability" of raw materials. With that regard, we established a workflow to: i) predict potential feeding issues, such as the flow stagnation in the hopper based on both the material attributes and the feeder's geometry; and ii) predict the feed rate space using various feeder/screw combinations for powders with an acceptable risk of hopper flow stagnation. Statistical models were developed for this twofold approach using a dataset comprising nine powders and four different feeders. In order to include different feeding equipment into the statistical models, novel equipment descriptors (capturing the effect of different geometries) and performance indicators (the end fill level as indicator for the risk of powder flow stagnation) were introduced. The application of the workflow was demonstrated for a simple formulation, and model validation was successfully performed for an additional powder that was not contained in the original dataset. Finally, the most relevant material attributes were identified, and reduced material characterization data sets were investigated in terms of effects on the model's prediction performance. The workflow presents a promising tool for initial process assessment in early-phase development.


Assuntos
Química Farmacêutica , Tecnologia Farmacêutica , Pós , Fluxo de Trabalho , Emolientes
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