Postnatal care and acceptability of emollient therapy in very low birthweight infants in Harare, Zimbabwe: a qualitative analysis.

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.

Manuka oil based ECMT-154 versus vehicle control for the topical treatment of eczema: study protocol for a randomised controlled trial in community pharmacies in Aotearoa New Zealand.

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).

Neonatal emollient therapy and massage practices in Africa: a scoping review.

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.

Efficacy of castor oil cream in treating infraorbital hyperpigmentation: An exploratory single-arm clinical trial.

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.

Randomized Phase 3 trial demonstrating high efficacy, favourable safety and convenience of a novel calcipotriol and betamethasone dipropionate cream for the treatment of psoriasis.

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.

Atopic Dermatitis.

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.

Supplement Individual Article: A Reappraisal of Fixed-Combination Halobetasol Propionate and Tazarotene for the Treatment of Psoriasis: Biological Underpinnings, Therapeutic Mechanisms, and Economic Considerations.

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.

A Potential Alternative Treatment for Vitiligo: An Observational Study on Tacrolimus 0.3% Lotion.

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%.

European guideline (EuroGuiDerm) on atopic eczema - part II: non-systemic treatments and treatment recommendations for special AE patient populations.

The evidence- and consensus-based guideline on atopic eczema was developed in accordance with the EuroGuiDerm Guideline and Consensus Statement Development Manual. Four consensus conferences were held between December 2020 and July 2021. Twenty-nine experts (including clinicians and patient representatives) from 12 European countries participated. This second part of the guideline includes recommendations and detailed information on basic therapy with emollients and moisturizers, topical anti-inflammatory treatment, antimicrobial and antipruritic treatment and UV phototherapy. Furthermore, this part of the guideline covers techniques for avoiding provocation factors, as well as dietary interventions, immunotherapy, complementary medicine and educational interventions for patients with atopic eczema and deals with occupational and psychodermatological aspects of the disease. It also contains guidance on treatment for paediatric and adolescent patients and pregnant or breastfeeding women, as well as considerations for patients who want to have a child. A chapter on the patient perspective is also provided. The first part of the guideline, published separately, contains recommendations and guidance on systemic treatment with conventional immunosuppressive drugs, biologics and janus kinase (JAK) inhibitors, as well as information on the scope and purpose of the guideline, and a section on guideline methodology.

Effectiveness and safety of tofacitinib combined with narrowband ultraviolet B phototherapy for patients with refractory vitiligo in real-world clinical practice.

Vitiligo is a chronic treatment-resistant autoimmune disorder characterized by circumscribed depigmented maculae. This study was conducted to evaluate the efficacy and safety of tofacitinib combined with narrowband ultraviolet B (NB-UVB) phototherapy for refractory nonsegmental vitiligo. Fifteen patients with nonsegmental vitiligo resistant to conventional therapies were administered oral tofacitinib at 5 mg twice daily plus topical halometasone cream, tacrolimus 0.1% ointment, or pimecrolimus cream twice daily and NB-UVB three times per week for 16 weeks. The control group comprised 19 patients with nonsegmental vitiligo treated with topical drugs plus NB-UVB same as the combination group. Treatment efficacy was measured by the percentage of repigmentation of vitiligo lesions at 4th, 8th, 12th, and 16th week after beginning treatment. From 8th week, the repigmentation level was significantly higher in the combination group than in the controls. From fourth week, the response rate was significantly higher in the combination group than in the controls. Only one patient in the combination group reported mild pain in the hand and foot joints, but the pain subsided with cessation of therapy. No other severe adverse effects occurred. So, tofacitinib in combination with NB-UVB phototherapy may be an effective and safe alternative modality for refractory vitiligo.

Evaluation of safety and efficacy of topical 4% nicotinamide in treatment of psoriasis; among a representative sample of Egyptians (an analytical observational study).

To assess and evaluate the efficacy and safety of nicotinamide 4% topical formulation for the treatment of mild to moderate psoriasis. This study was conducted on 60 patients aged 18-65 years, with mild to moderate psoriasis vulgaris. Nicotinamide 4% in a cold cream base was used twice daily for 12 weeks. Nicotinamide 4% topical treatment shows satisfactory results, more in males than in females. Some patients report disturbing irritation (burning, itching, and redness) upon the usage of topical nicotinamide treatment and were advised to wash out the treated area after 1 h of cream application, which solved the issue. No other adverse effects of treatment were reported by patients during the study period. Unicentral base, a limited amount of sample size, and 12 weeks duration of therapy and follow-up period, which may not be sufficient to demonstrate the complete therapeutic properties and side effects of using nicotinamide as a long-term treatment for psoriasis. This study reveals statistically reliable evidence of the positive impact of topical 4% nicotinamide preparation used alone on the treatment of psoriasis with minimal side effects. Thus, we can conclude that topical nicotinamide preparation may be a good adjuvant to the current treatment regimens used alone or alternate currently used topical therapeutical regimens if used in combination.

Efficacy of a retinoid complex plus anti-inflammatory component cream alone or in combination with prebiotic food supplement in adult acne: A randomized, assessor-blinded, parallel-group, multicenter trial on 184 women.

BACKGROUND: Adult female acne (AFA) nowadays is a very common skin condition affecting mainly women aged between 25 and 40. The treatment of AFA could be challenging. STUDY AIM: We evaluate and compare the efficacy and tolerability of a cream formulation containing two retinoid molecules (hydroxypinacolone/retinyl palmitate) combined with Iris Florentina root extract and a complex of three oligopeptides (C) applied twice a day (morning and evening) alone or in combination (C + O) with a food supplement containing a mixture of prebiotic molecules (FOS&GOS) zinc, lactoferrin, and niacinamide. SUBJECTS AND METHODS: In a multicenter, randomized, assessor-blinded, 12-week trial, we assessed the efficacy of these two regimens in the evolution of AFA lesions (non-inflammatory: NI-L; inflammatory: IL; and total number of lesions: TL). Additional efficacy endpoints were the evolution of the 6-point (from 0 to 5) GEA and Adult Female Acne Scoring Tool (AFAST) scores. RESULTS: One hundred and eighty-four women (mean age 32 ± 6 years) with AFA agreed to participate after obtaining informed consent. They were randomized (2:1) to the topical product (n = 123) (Group C) or to the combination (n = 61) (Group C + O) treatment. All enrolled patients concluded the trial with no drop-out. At baseline, NI-L, IL, and TL acne lesion count were 15 ± 9, 9 ± 5, and 24 ± 14 in the Group C and 19 ± 8, 9 ± 4, and 29 ± 10 in Group C + O. In comparison with the number of the acne lesions at the baseline, both treatment regimens induced a significant reduction (p = 0.0001, ANOVA test) at Week 12 in NI-L, IL, and TL by -54%, -63%, and - 59% in Group C and by -55%, -73%, and - 61% in the Group C + O, respectively. At Week 12, the absolute IL count reduction vs. baseline was significantly (p = 0.0158) greater in Group C + O (-7.0) in comparison with Group C (-5.5). The GEA absolute score reduction in Group C + O group was significantly greater in comparison with Group C (-1.5 vs. -1.1; p = 0.0097). In the Group C + O, a greater percentage of success treatment (defined as a GEA score of 0/1 at Week 12) was observed in comparison with Group C (39% vs. 27%; p = 0.06). AFAST score at baseline was 2.4 ± 0.5 in group C and 2.8 ± 0.6 in group C + O. AFAST score was reduced by 21% and by 51% after 6 and 12 weeks of treatment in group C and by 22% and 55% in group C + O, respectively. Both treatment regimens were well tolerated. Not relevant adverse events were recorded. CONCLUSION: A cream containing retinoid molecules and Iris Florentina root extract is effective and well tolerated in the management of AFA. The treatment combination with a prebiotic and anti-inflammatory food supplement offers an additional clinical benefit mainly in reducing inflammatory lesions and improving the severity acne score.

Comparison of the efficacy of cysteamine 5% cream and hydroquinone 4%/ascorbic acid 3% combination cream in the treatment of epidermal melasma.

BACKGROUND: Few safe and effective treatments are available for melasma. Cysteamine, a non-melanocytotoxic molecule is a safer alternative to hydroquinone and usable for long-term use. AIM: To evaluate the effect of cysteamine 5% cream in the treatment of melasma. METHODS: Sixty-five of 80 patients completed this single-blind, randomized, controlled trial. The patients received cysteamine 5% or hydroquinone 4%/ascorbic acid 3% (HC) cream. The therapeutic response was evaluated by modified MASI (mMASI) and melanin index (SkinColorCatch) after 2 and 4 months of treatment. The effect of treatment on the quality of life was also assessed. RESULTS: The decrease in mMASI score was from 6.69 ± 2.96 to 4.47 ± 2.16 in the cysteamine group and from 6.26 ± 3.25 to 3.87 ± 2.00 in the HC group after 4 months (p values < 0.001). The melanin index decreased from 37.72 ± 10.17 to 31.47 ± 11.90 in the cysteamine group and from 36.37 ± 10.80 to 23.16 ± 8.83 in the HC group after 4 months (p-value = 0.003 and <0.001, respectively). The difference between mMASI score at baseline and month 4 was not significant between both groups (p-value > 0.05). The difference between the melanin index at baseline and month 4 was significantly more pronounced in the HC group (p-value = 0.002). Quality of life improved in both groups (p-value < 0.05), but was not significantly different between groups (p-value > 0.05). CONCLUSION: Cysteamine was confirmed to be an effective treatment for melasma, with equivalent results to HC in reducing mMASI score and improving quality of life, despite lesser melanin index reduction observed. Cysteamine and HC efficacy was confirmed in patients recalcitrant to previous treatments, by a significant reduction of mMASI and melanin index.

Effects of a moisturizer containing pseudo-ceramide and a eucalyptus extract on sweating function in adult atopic dermatitis: a double-blind, randomized, controlled left-right comparison clinical trial.

BACKGROUND: Many patients with atopic dermatitis (AD) have a decreased ability to sweat. Several factors can cause decreased perspiration, such as weak tight junctions of sweat ducts, reduced acetylcholine receptor function, and inhibition of perspiration by histamines. Parakeratosis of AD skin also decreases sweating by occluding sweat pores. Increased ceramide levels in the stratum corneum reduce parakeratosis by improving stratum corneum functions. Furthermore, ceramides and/or ceramide derivatives may affect claudin-3 and acetylcholine receptors. OBJECTIVE: In this study, we investigated the efficacy of a moisturizer containing pseudo-ceramide and a eucalyptus extract to increase ceramide levels in the epidermis to improve the sweating ability of patients with AD. METHODS: Nineteen patients with AD applied moisturizers with or without pseudo-ceramide and a eucalyptus extract on the cubital fossa of either arm twice a day for 4 weeks. Skin conditions and sweating ability, measured as the response to acetylcholine stimulation, were evaluated prior to the start of the study (Week 0) and at the end of Weeks 2 and 4. RESULTS: Both moisturizers improved the visually evaluated skin symptoms and skin hydration. However, only the moisturizer containing pseudo-ceramide and the eucalyptus extract significantly improved cutaneous barrier function and significantly increased the ceramide level in the stratum corneum. That moisturizer also increased the sweating volume and shortened the latency time for sweating, an indicator of sweating ability, but the other moisturizer did not. CONCLUSION: Based on these results, the moisturizer containing pseudo-ceramide and a eucalyptus extract helps recover the sweat function of AD patients.

Therapeutic effects of turmeric topical cream in vitiligo: A randomized, double-blind, placebo-controlled pilot study.

BACKGROUND: Vitiligo is an autoimmune and acquired disease characterized by the destruction of epidermal melanocytes leading to depigmentation of the skin. Although vitiligo is a common disease, there is not a definite cure and conventional therapies can lead to serious adverse effects. Turmeric has been widely studied for its anti-inflammatory, antioxidant, and anti-cell proliferation, while it is a cost-benefit and available treatment for a variety of diseases. AIMS: The aim of this study was to evaluate the efficacy of topical turmeric cream on vitiligo's lesion appearance including size and repigmentation. PATIENTS/METHODS: Following the screening, 30 patients were enrolled according to inclusion criteria. The patients received training to apply turmeric and placebo cream at the specified side of their body twice a day for 4 months. Patients were evaluated at the baseline and at monthly intervals to access possible side effects. Lesion size, vitiligo area scoring index (VASI), vitiligo noticeability scale (VNS), and physician global assessment (PGA) were evaluated at the baseline and after four months to compare the changes induced by turmeric and placebo cream. RESULTS: Twenty-four patients completed the trial. Applying turmeric cream reduced the size of lesions and improved lesion's appearance significantly compared to the placebo group (p < 0.001), and also, patient's satisfaction score was higher following applying turmeric cream compared to placebo (p < 0.05). CONCLUSIONS: Turmeric cream can be used as an alternative remedy or adjuvant therapy in mild to moderate vitiligo lesions and in those who cannot tolerate the adverse effects of conventional therapies.

The efficacy of topical Marham-e-Akbar in chronic atopic dermatitis - an open-label interventional study.

OBJECTIVES: Chronic atopic dermatitis (AD) is an inflammatory skin condition marked by intense pruritus, dry skin, and severe impact on the life quality of the patients. Conventionally, it is managed by using emollients, calcineurin inhibitors, and topical corticosteroids. In Unani medicine, eminent scholars advocated many drug formulations including topical Marham-e-Akbar for effective healing of AD but scientific evidence is scarce. Hence, this study was designed. METHODS: This was a single-arm clinical trial conducted on 30 participants aged 18-65 years suffering from chronic AD after obtaining written informed consent. The trial intervention was Marham-e-Akbar consisting of Murdar Sang (Plumbi oxidum); Sindur (red lead); olive oil (Olea europaea oil); Kath (Acacia catechu extract); Safeda Kashgari (Zinc oxide); Sirka (vinegar); and Phitkiri (alum) to be applied twice daily for 42 days. The objective parameters were SCORAD and DLQI, while the subjective parameters included itching, scaling, and erythema assessed on a customized VAS scale and 4-point Likert scale. RESULTS: The pre-post analysis inferred statistically significant attenuation in subjective parameters (itching, scaling, and erythema) and objective scales (SCORAD) and (DLQI) with p<0.001. CONCLUSIONS: The study findings deduced that Marham-e-Akbar is effective in the amelioration of chronic atopic dermatitis and quality of life of the patients as well.

Assessment of the efficacy, skin acceptability and cosmetic quality of an adjuvant cream based on 40% urea and amino-inositol in the treatment of mild psoriasis.

BACKGROUND: Psoriasis is a chronic inflammatory disease with a multifactorial genesis. Structural changes are encountered in psoriasis and skin barrier function is impaired. Tight junctions (TJs) play a key role in skin barrier dysfunction. Loss of profilaggrin or filaggrin leads to changes in the stratum corneum and consequent loss of water and the development of xerosis. METHODS: We carried out an observational study to evaluate the efficacy, skin acceptability and cosmetic qualities of a cream formulation, based on 40% urea and amino-inositol, in the treatment of mild psoriasis in the absence of other associated cosmetic/pharmacological treatments. All parameters were evaluated before (T0) and after 4 weeks (T4). Efficacy assessment was based on both clinical evaluation and photographic documentation. RESULTS: The results showed significant clinical improvement (-64.18% PASI, -57.11% BSA, -61.84% Plaque Score, -41.86% PGA and -76.34% VAS -77.5 DLQI) in 4 weeks of treatment. No significant side effects were reported. Similarly, the degree of satisfaction with the product and adherence to its use were particularly satisfactory among patients. CONCLUSIONS: The tested product was found to be a promising, effective adjuvant treatment in patients with mild psoriasis, and was also useful in reducing itchy symptoms, the impact on quality of life, as well as significantly reducing the clinical signs of psoriasis.

Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial.

BACKGROUND: Hospitalized preterm infants with compromised skin barrier function treated topically with sunflower seed oil (SSO) have shown reductions in sepsis and neonatal mortality rate (NMR). Mustard oil and products commonly used in high-mortality settings may possibly harm skin barrier integrity and enhance risk of infection and mortality in newborn infants. We hypothesized that SSO therapy may reduce NMR in such settings. METHODS AND FINDINGS: This was a population-based, cluster randomized, controlled trial in 276 clusters in rural Uttar Pradesh, India. All newborn infants identified through population-based surveillance in the study clusters within 7 days of delivery were enrolled from November 2014 to October 2016. Exclusive, 3 times daily, gentle applications of 10 ml of SSO to newborn infants by families throughout the neonatal period were recommended in intervention clusters (n = 138 clusters); infants in comparison clusters (n = 138 clusters) received usual care, such as massage practice typically with mustard oil. Primary analysis was by intention-to-treat with NMR and post-24-hour NMR as the primary outcomes. Secondary analysis included per-protocol analysis and subgroup analyses for NMR. Regression analysis was adjusted for caste, first-visit weight, delivery attendant, gravidity, maternal age, maternal education, sex of the infant, and multiple births. We enrolled 13,478 (52.2% male, mean weight: 2,575.0 grams ± standard deviation [SD] 521.0) and 13,109 (52.0% male, mean weight: 2,607.0 grams ± SD 509.0) newborn infants in the intervention and comparison clusters, respectively. We found no overall difference in NMR in the intervention versus the comparison clusters [adjusted odds ratio (aOR) 0.96, 95% confidence interval (CI) 0.84 to 1.11, p = 0.61]. Acceptance of SSO in the intervention arm was high at 89.3%, but adherence to exclusive applications of SSO was 30.4%. Per-protocol analysis showed a significant 58% (95% CI 42% to 69%, p < 0.01) reduction in mortality among infants in the intervention group who were treated exclusively with SSO as intended versus infants in the comparison group who received exclusive applications of mustard oil. A significant 52% (95% CI 12% to 74%, p = 0.02) reduction in NMR was observed in the subgroup of infants weighing ≤1,500 g (n = 589); there were no statistically significant differences in other prespecified subgroup comparisons by low birth weight (LBW), birthplace, and wealth. No severe adverse events (SAEs) were attributable to the intervention. The study was limited by inability to mask allocation to study workers or participants and by measurement of emollient use based on caregiver responses and not actual observation. CONCLUSIONS: In this trial, we observed that promotion of SSO therapy universally for all newborn infants was not effective in reducing NMR. However, this result may not necessarily establish equivalence between SSO and mustard oil massage in light of our secondary findings. Mortality reduction in the subgroup of infants ≤1,500 g was consistent with previous hospital-based efficacy studies, potentially extending the applicability of emollient therapy in very low-birth-weight (VLBW) infants along the facility-community continuum. Further research is recommended to develop and evaluate therapeutic regimens and continuum of care delivery strategies for emollient therapy for newborn infants at highest risk of compromised skin barrier function. TRIAL REGISTRATION: ISRCTN Registry ISRCTN38965585 and Clinical Trials Registry-India (CTRI/2014/12/005282) with WHO UTN # U1111-1158-4665.

[Influence of an adjuvant treatment with an emollient containing 10 % urea, ceramides, glycerin und glyceryl glucoside in patients with psoriasis vulgaris]. / Einfluss einer adjuvanten Basistherapie mit 10 % Urea, Ceramiden, Glycerin und Glyceryl Glucoside bei Patienten mit Psoriasis vulgaris.

BACKGROUND: Guidelines generally recommend an adjuvant treatment with emollients for patients suffering from psoriasis. However evidence for this purpose is limited. PATIENTS AND METHODS: We performed a prospective observational study with an emollient containing 10% urea, ceramides, glycerin and glyceryl glucoside in patients suffering from mild to moderate psoriasis. The patients had to be stable for at least 12 weeks on prior antipsoriatic therapy including topical therapy, systemic treatment or phototherapy which was continued during the trial. RESULTS: A 4-week daily application of the emollient resulted in significant improvement regarding quality of life (measured by DLQI, Dermatology Life Quality Index) and clinical outcome (measured by local PASI, Psoriasis Area and Severity Index) among the treated patients. CONCLUSION: The trial results show that a daily adjuvant treatment with emollients can support a basic antipsoriatic therapy both in aspects of clinical efficacy and quality of life in mild to moderate patients suffering from psoriasis.