Medihoney Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children: An Open-Label Randomized Pilot Study.

Abstract

To the Editor: Topical corticosteroids are considered the main treatment for atopic dermatitis (AD), especially during a flare.1 Although topical corticosteroids have enormous benefits in reducing inflammation, they may be accompanied by significant adverse effects. In addition, the worldwide prevalence of topical corticosteroids phobia is extremely high, ranging from 31% to 95.7%,2 and may lead to poor adherence, resulting in persistent disease and rapid escalation to systemic agents.2 To avoid these adverse effects and the excess use of topical corticosteroids, other topical treatment modalities for AD are needed.3 Medihoney Derma Cream (Med-D-Cream) is a topical emollient cream containing 30% Medihoney antibacterial honey, coconut oil, German chamomile flower extract, evening primrose oil, aloe vera, vitamin E, glucose oxidase, and Leptospermum compounds. It has broad antibacterial and antipruritic activity,4 and by preserving skin barrier integrity and moisture, it aids in maintaining skin pH. Med-D-Cream is licensed for skin and wound care in Australia, Europe, and the United States. To offer an alternative corticosteroid-sparing option for treating mild to moderate AD in children, we conducted a trial comparing the safety and efficacy of Med-D-Cream to a common mild potency corticosteroid cream used worldwide for the treatment of AD (hydrocortisone 1% cream). The trial comprised children aged 2 to 18 years diagnosed with mild to moderate AD, with an Investigator Global Assessment (IGA) score of 2 to 3 and body surface area (BSA) of 1% to 10%, including 30 patients, 20 using Med-D-Cream, and 10 as controls using hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed up for 2 more weeks to measure responses using IGA, BSA, Eczema Area and Severity Index score, SCORing Atopic Dermatitis, and Visual Analogue Scale pruritus (Fig. 1). The duration of treatment was limited to 2 weeks to avoid prolonged use of a topical steroid. The response rate (IGA score of 0 or 1 with at least 1-grade reduction after 2 weeks of treatment) was 47.4% (9/19) in the intervention group (Med-D-Cream) and 60% (6/10) in the control group (hydrocortisone 1% cream). There was no statistically significant difference between the 2 arms in response rates. No significant changes were found between the 2 groups regarding the secondary outcomes (BSA, Eczema Area and Severity Index score, SCORing Atopic Dermatitis, and Visual Analogue Scale pruritus). In the Med-D-Cream group, 2 of the 20 patients (10%) had adverse events, which resulted in 1 patient's withdrawal. No adverse events were seen in the hydrocortisone group. Our study had some limitations. First, we had a small sample size because it was a pilot study; however, the cohort size did allow us to draw statistical conclusions. Second, the study had relatively short treatment and follow-up periods (4 weeks overall), limiting the ability to observe potential allergic contact dermatitis and properly assess Med-D-Cream's effect on barrier function. Despite these limitations, this is the first randomized study designed to explore Med-D-Cream clinical activity and compare it with a topical corticosteroid in the pediatric population.Figure 1: Flowchart of the study design and population.In conclusion, the study demonstrated that Med-D-Cream, an emollient, is safe and effective in treating pediatric mild to moderate AD. Although it failed to show that Med-D-Cream had superiority over hydrocortisone 1% cream, it showed comparable clinical efficacy. Amir Horev Pediatric Dermatology Service Soroka University Medical Center Beer Sheva, Israel Faculty of Health Sciences Ben-Gurion University of the Negev Beer Sheva, Israel [email protected]Maayan SherSarah Weissmann Faculty of Health Sciences Ben-Gurion University of the Negev Beer Sheva, IsraelLior Golan Faculty of Health Sciences Ben-Gurion University of the Negev Beer Sheva, Israel Clinical Research Unit Soroka University Medical Center Beer Sheva, IsraelAnat Horev Neurology Department Soroka University Medical Center Beer Sheva, Israel