Managing dry skin in patients with comorbidities or with advanced age: unmet needs and roles for products containing potential emollient-plus ingredients.

In dry skin (DS), skin-barrier function is easily disturbed and moisturizing factors in the stratum corneum are reduced. Despite being a common condition, DS is often overlooked in patients with advanced age or comorbid diseases. In September 2022, specialists in dermatology and skin care met to discuss unmet needs and management of patients with DS with existing medical conditions or DS induced by ongoing pharmacological treatments. There was consensus about the need to improve the current understanding and management of DS in patients with comorbidities, including type 2 diabetes, chronic kidney disease, radiodermatitis, and photodamaged skin. Clinical guidance related to optimal treatment of DS in patients with advanced age or comorbid diseases is needed. Dexpanthenol-containing emollients have been shown to provide rapid relief from the symptoms and clinical signs of skin inflammation and are well-tolerated and effective in terms of moisturizing and soothing DS and maintaining skin-barrier function. Thus, dexpanthenol-containing emollients may play an important role in future management of DS. Further research is needed to elucidate the efficacy of dexpanthenol across the spectrum of DS, irrespective of comorbidity status or age.

Rebalancing of the skin microbiome with an emollient 'plus' for effective management of atopic dermatitis: A mini review.

A balanced and diverse skin microbiome is pivotal for healthy skin. Dysregulation of the skin microbiome could disrupt the skin barrier function and result in the development of atopic dermatitis (AD), a common chronic and relapsing inflammatory skin disorder. Given the role that the skin microbiome plays in the initiation and maintenance of AD, maintaining a healthy skin microbiome is crucial for effective disease management. Specifically, current guidelines recommend emollients as the treatment mainstay in maintaining a functional skin barrier across disease severity. Emollient 'plus' or therapeutic moisturisers have recently emerged as the next-generation emollients that specifically aim to rebalance the skin microbiome and subsequently improve AD lesions. This article provides a quick overview of an emollient 'plus' or therapeutic moisturiser, discussing the clinical efficacy and tolerability of Lipikar Baume AP+M as a companion in AD management.

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.

Role of skin management in the prevention of atopic dermatitis and food allergy.

Food allergy is postulated to originate from cutaneous sensitization through a disrupted skin barrier, particularly in atopic dermatitis (AD). Strategies for food allergy prevention currently centre around early allergic food introduction, but there is now increasing evidence for the role of early skin barrier restoration in the form of prophylactic emollient therapy and early aggressive, proactive treatment of established AD for food allergy prevention. Research gaps that remain to be addressed include the type of emollient or anti-inflammatory medication, which confers the greatest efficacy in preventive or proactive skin treatment, respectively, the duration of therapy, and the window of opportunity for these interventions.

Real-World Use of Ruxolitinib Cream: Safety Analysis at 1 Year.

BACKGROUND: Ruxolitinib cream is the first topical Janus kinase (JAK) inhibitor approved in the United States (US) for the treatment of mild to moderate atopic dermatitis and nonsegmental vitiligo. A postmarketing study with oral tofacitinib, approved for rheumatoid arthritis, triggered class warnings for JAK inhibitors, including risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. Because ruxolitinib cream is indicated for inflammatory conditions, it is subject to the same warnings as oral JAK inhibitors in the US. Here, nearly 14,000 patient-years of postmarketing safety data from the first year following market approval of ruxolitinib cream were reviewed. METHODS: The Incyte global safety database (21 September 2021-20 September 2022) and US FDA Adverse Event Reporting System (as of 30 September 2022) were queried for adverse event (AE) reports received for ruxolitinib cream. RESULTS: The search identified 294 postmarketing individual case safety reports containing 589 events, including four serious AEs and no fatal AEs. AEs (i.e., any unfavorable sign, symptom, or disease) representing >2% of all events included application site pain (n = 16), atopic dermatitis (n = 15), skin irritation (n = 15), scratch (n = 14), and condition aggravated (n = 13). The four serious AEs were skin cancer (n = 2), pericarditis, and thrombocytopenia (both n = 1), none of which had sufficient information to assess possible relatedness to ruxolitinib cream. Serious AEs associated with the class warnings for JAK inhibitors were not reported. CONCLUSIONS: Postmarketing safety data from the year following approval suggest ruxolitinib cream is generally well tolerated, without significant systemic AEs, and with a low incidence of application site reactions.

Adult, adolescent, and caregiver preferences for attributes of topical treatments for mild-to-moderate atopic dermatitis: a discrete-choice experiment.

Purpose: Topical treatments for mild-to-moderate (MM) atopic dermatitis (AD) include emollients, corticosteroids, calcineurin inhibitors, a Janus kinase inhibitor, and a phosphodiesterase 4 inhibitor, which differ in multiple ways. This study aimed to quantify the conditional relative importance (CRI) of attributes of topical treatments for MM AD among adult and adolescent patients and caregivers of children with MM AD.Materials and methods: A discrete-choice experiment (DCE) survey was administered to US adults and adolescents with MM AD and caregivers of children with MM AD. Each choice task comprised 2 hypothetical topical treatments characterized by efficacy, adverse events, vehicle, and application frequency. Data were analyzed using a random-parameters logit model to calculate the CRI of each attribute.Results and conclusions: 300 adults, 331 adolescents, and 330 caregivers completed the DCE. Avoiding changes in skin color (CRI 29.0) and time until itch improves (26.6) were most important to adults, followed by time until clear/almost clear skin (17.8). Application frequency (3.0) did not have a statistically significant impact on adults' choices. Adolescents were less concerned about changes in skin color than adults or caregivers; caregivers were less concerned about time until clear/almost clear skin than patients. Physicians should consider age-relevant aspects of preferences in treatment discussions with patients and caregivers.

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).

Evaluation of the benefit of the addition of 1% topical luliconazole versus topical bland emollient to the systemic itraconazole therapy for the management of disseminated dermatophytosis: A randomised control trial.

BACKGROUND: The present epidemic of dermatophytosis in India is marked by an increase in chronic, recurrent and disseminated cases. A combination of oral itraconazole and topical luliconazole is being increasingly utilised by dermatologists in India. The superiority of this combination is not supported by robust clinical trial data. OBJECTIVE: We conducted this randomised, open-label, two arms, parallel assignment intervention trial between November 2022 and May 2023 to determine the superiority of topical 1% Luliconazole over bland emollient as adjuvant to systemic Itraconazole therapy in the management of dermatophytosis. METHOD: In this study, 135 patients of either sex were randomised to two study cohorts. Major exclusions being concomitant medical illness, use of concomitant medication and substance abuse. Participants were randomly assigned to receive topical bland emollient, (Cohort I, n = 67) or topical luliconazole, (Cohort II, n = 68). Both cohorts received oral itraconazole 200 mg/day (100 mg BID) and levocetirizine 5 mg twice a day as a systemic regime. Clinical and mycological cure at the end of 6 weeks and clinical relapse among cure patients during 10-week follow-up were observed. RESULTS: The cure rates for Cohorts I and II at 6 weeks were 50 (74.62%) and 56 (82.35%), (p = .46), respectively. During the 4-week follow-up period, clinical relapses were observed in 16 (32%) of the 50 patients in Cohort I and 12 (21.43%) of the 56 patients in Cohort II (p = .18). Luliconazole cohort shows a significantly higher medical cost (p < .05). CONCLUSION: Our study shows a similar cure rate and relapse rate for patients receiving topical Luliconazole versus topical bland emollient as an adjuvant to the systemic itraconazole regime.

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.

Cream versus ointment: Randomized single-blinded study on the adherence to treatment with topical methylprednisolone aceponate.

BACKGROUND: Overall adherence in the treatment of chronic dermatoses is poor. Textbooks state an adherence dependence on galenics. TRIAL DESIGN: Prospective, randomized, parallel-grouped, single-blinded (investigator), monocentric clinical trial (phase IV) on the adherence to treatment of chronic mild to moderate hand eczema with topical methylprednisolone aceponate (MPA, Advantan®) in different vehicles. OBJECTIVES AND ENDPOINTS: Primary objective was the assessment of the adherence depending on vehicle type in patients with chronic hand eczema. Secondary objective was improvement after a 4-week treatment period. Primary Endpoint Adherence is defined as the percentage of patients applying at least aimed daily dose. Prescribed daily dose was defined as the planned number of applications per day (1) * surface (measured) * aimed amount per application (mg/cm2 ). Truly applicated daily dose was evaluated as individual mean amount per dose * individual mean number of applications per day. Adherence was assumed, if truly applicated daily dose is at least 75% of the prescribed daily dose and the individual mean number of applications per day is at least 0.85. Secondary Endpoint Efficacy was measured by improvement of Hand Eczema Severity Index (HECSI) and Investigator's Global Assessment (IGA) after a 4-week treatment period and in addition to Quality of Life in Hand Eczema Questionnaire (QOLHEQ) and Visual Analogue Scale (VAS) to assess pruritus. METHODS: Number of participants randomized to each group 40, 80 total. Group 1 MPA-C: Methylprednisolone aceponate 0.1% cream and barrier repair emollient (Bepanthen® Sensiderm). Group 2 MPA-FO: Methylprednisolone aceponate 0.1% fatty ointment and barrier repair emollient (Bepanthen® Sensiderm). Adherence to treatment was compared via Fisher's exact test. RESULTS: Of the patients, 48% were adherent according to our definition. There was no significant difference between MPA-C (42.1%) and MPA-FO (54.1%; p = 0.36; group difference-12.0%, 95% CI-34.3%-11.5%). Generalized-linear-model-analysis of adherence to study treatment with factors emollient use, treatment, time and treatment-time interaction showed a parallel between adherence and amount of emollient use (odds ratio 1.74, p = 0.0038; 95% CI-1.22-2.52). Improvement of hand eczema was seen according to clinical scores without remarkable differences between the groups. CONCLUSIONS: No dependence of adherence on galenics of topical treatment of chronic hand eczema could be proved. Patients who use more emollient tend to be more adherent to the topical treatment.

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.

Comparing emollient use with topical luliconazole (azole) in the maintenance of remission of chronic and recurrent dermatophytosis. An open-label, randomized prospective active-controlled non-inferiority study.

BACKGROUND: Literature on emollient use in the management of chronic and recurrent dermatophytosis is limited. OBJECTIVE: To assess the efficacy of emollient in the remission maintenance of chronic and recurrent dermatophytosis. METHODS: In this randomized open-label study with the intention to treat, 80 patients with chronic recurrent dermatophytosis were randomized into two groups, where both groups were treated adequately for 6 weeks, followed by continuation of topical azole in group A and topical emollient in group B for 6 weeks. Clinical remission was determined by disappearance signs and symptoms of tinea lesions with or without hyperpigmentation. Physician and patient global assessment scores were evaluated every 2 weeks for 6 weeks to assess remission maintenance. RESULTS: A total of 80 patients of chronic and recurrent dermatophytosis were assessed for remission maintenance. The recurrence of disease occurred in 20 patients overall, wherein 7 patients (17.5%) in group A and 13 patients (32.5%) in group B at the end of the study (18 weeks); however, the difference between the two groups was not statistically significant (p = .121). The mean physician global assessment scores of group A and group B at 12 weeks were 4.45 ± 0.74 and 4.15 ± 0.92, 4.43 ± 0.90 and 4.10 ± 0.98 at 14 weeks, 4.0 ± 1.32 and 3.98 ± 1.23 at 16 weeks, 3.85 ± 1.44 and 3.90 ± 1.35 at 18 weeks, respectively. The mean patient global assessment scores of group A and group B were 4.65 ± 0.62 and 4.25 ± 0.87 at 12 weeks, 4.40 ± 0.87 and 4.17 ± 0.98 at 14 weeks, 4.18 ± 1.15 and 4.12 ± 1.30 at 16 weeks and 3.97 ± 1.33 and 3.90 ± 1.51 at 18 weeks. CONCLUSION: The present study concludes that the efficacy of emollient was not inferior to topical luliconazole for maintaining remission in chronic and recurrent dermatophytosis.

ZORYVETM (Roflumilast) Cream: A Topical Phosphodiesterase-4 Inhibitor for the Treatment of Psoriasis.

ZORYVETM (roflumilast) cream is a topical phosphodiesterase-4 (PDE-4) inhibitor that has been recently approved for the treatment of plaque psoriasis. It is also indicated for use in intertriginous areas. Roflumilast, the active ingredient, inhibits PDE-4, leading to the suppression of pro-inflammatory immune responses in psoriatic lesions. Two phase 3 clinical trials have demonstrated the efficacy of once daily application of roflumilast to treat plaque psoriasis in patients aged 12 years and older. At week 8, an investigator's global assessment score of 0 or 1 with a grade 2 improvement from baseline, the primary efficacy end point, was observed in 39.1% (225/576) of patients applying roflumilast, compared to 6.6% (20/305) of patients applying vehicle. Common adverse events reported were diarrhea, headache, insomnia, nausea, pain at application site, upper respiratory tract infection, and urinary tract infection.

An easy to use, ceramide-containing skincare routine: effectiveness and improvement of quality of life in elderly patients with xerosis.

BACKGROUND: Xerosis negatively impacts the quality of life (QoL) for older adults by producing pruritus (itching), burning or stinging, and an uncomfortable sensation of tightness in the skin. Furthermore, chronic illness and pharmacological therapies could worsen skin health. Severe xerosis can also result in redness or cracking of the skin. The aim of this prospective open-label trial is to evaluate the effectiveness of a ceramide-based moisturizing cream and cleanser routine on elderly xerosis. METHODS: During the 4-week treatment study, patients followed the routine according to the established protocol. At different timepoints (baseline, visit 1; after 28±5 days, visit 2) evaluations on the skin health and QoL of the patients were conducted by a healthcare professional (HCP), along with a patients' self-evaluation. RESULTS: The study demonstrates that the treatment with the investigated products determines an overall significant improvement in all skin dryness criteria. In particular, after the observational period: 93% of the subjects had no or minimal skin roughness; 96% of patients had no or minimal discomfort due to skin dryness; 97% of patients did not present any fissures; patient self-assessments on skin dryness were consistent with HCP evaluation. QoL has globally improved in all patients, with a significant reduction of embarrassment, and a positive impact on social and daily activities. Patients' overall satisfaction was high in 87% of patients and 93% of them stated that they would continue the treatment also after the study had been completed. CONCLUSIONS: After 4 weeks, the daily use of a ceramide-based routine significantly improved signs and symptoms of senile xerosis and chronic discomfort associated with xerosis in elderly adults. Furthermore, the impact of senile xerosis on subjects' QoL was also reduced after 4 weeks. The subjects also reported high satisfaction with the skincare regimen and its results.

Frequency of newborn bathing in the first 9 weeks of life and related factors: An observational study in a community-based sample from Meta-LARC.

PURPOSE: Environmental factors such as bathing may play a role in atopic dermatitis (AD) development. This analysis utilized data from the Community Assessment of Skin Care, Allergies, and Eczema (CASCADE) Trial (NCT03409367), a randomized controlled trial of emollient therapy for AD prevention in the general population, to estimate bathing frequency and associated factors within the first 9 weeks of life. METHODS: Data were collected from 909 parent/newborn dyads recruited from 25 pediatric and family medicine clinics from the Meta-network Learning and Research Center (Meta-LARC) practice-based research network (PBRN) consortium in Oregon, North Carolina, Colorado, and Wisconsin for the CASCADE trial. Ordinal logistic regression was used to conduct a cross-sectional analysis of the association between bathing frequency (measured in baths per week) and demographic, medical, and lifestyle information about the infant, their family, and their household. Variables were selected using a backwards-stepwise method and estimates from the reduced model are reported in the text. RESULTS: Moisturizer use (OR = 2.03, 95% CI: 1.54-2.68), Hispanic or Latino ethnicity (OR = 1.97, 95% CI: 1.42-2.72), a parental education level lower than a 4-year college degree (OR = 2.48, 95% CI: 1.70-3.62), living in North Carolina or Wisconsin (compared to Oregon; OR = 2.12 and 1.47, 95% CI: 1.53-2.93 and 1.04-2.08, respectively), and increasing child age (in days; OR = 1.02, 95% CI: 1.01-1.02) were significantly associated with more frequent bathing, while pet ownership (OR = 0.67, 95% CI: 0.52-0.87) was significantly associated with less frequent bathing. CONCLUSIONS: We found significant ethnic, geographic, and socioeconomic variation in bathing frequency before 9 weeks of age that may be of relevance to AD prevention studies.

Individual Article: Efficacy of Over-The-Counter Cream in Reducing Eczema Signs.

BACKGROUND: Eczema (also called atopic dermatitis) is a chronic, relapsing skin disease characterized by erythema, scaling, and pruritus. METHODS: Study 1. A double-blind, uncontrolled study in patients with mild-moderate eczema, ≥2 flares in prior 2 months, and baseline Scoring Atopic Dermatitis (SCORAD) score ≤15. Participants applied Eczema Flare-Up Relief Cream (EFRC) (N=65) BID for 56 days. Efficacy was assessed by SCORAD, patient-oriented SCORAD, skin sensitivity, Dermatology Life Quality Index (DLQI), and digital photography. Standard safety assessments were performed. STUDY 2: A 21-day open study of EFRC (N=50) to evaluate tolerability as well as its effect on eczema.  Results: Study 1. EFRC significantly reduced overall SCORAD scores from baseline to day 56 (11.6 to 4.9, or a 57% reduction). The patient-oriented SCORAD was reduced from 18.6 to 6.8 from baseline to day 56. At day 56, itch and pain improved in 70.4% of children and 62% of adults. DLQI scores were decreased by 75% in adults and 61% in children by day 56. Global skin sensitivity, assessed by the Sensiscale 10-item questionnaire, was 13.1 at baseline and 3.6 at day 56, an improvement of 72%. STUDY 2: EFRC improved eczema-prone skin after 7 and 21 days.  Conclusions: Study 1 showed that EFRC had good efficacy with significant reductions in overall SCORAD scores and subscores for the extent and intensity of eczema and subjective symptoms. Skin sensitivity also improved along with quality of life. Studies 2-3 also had significantly positive results and good tolerability. J Drugs Dermatol. 2023;22:10(Suppl 2):s5-9.