A Phase II Trial to Assess the Safety and Efficacy of a Topical Repair Cream Containing Skin-identical Ceramide Complex in Patients with Contact Dermatitis

摘要

>Background: Contact dermatitis is a common skin condition observed by dermatologists, presenting a burden on healthcare systems. Recently, there has been a trend in producing skin-identical topical preparations for the repair of skin. However, there is a limited number of experimental studies to assess the safety and efficacy of this products. >Objective: This study assessed the clinical efficacy and safety of a skin-identical ceramide complex cream (Dermalex Repair Contact Eczema; Omega Pharma, Nazareth, Belgium) in the treatment of contact dermatitis. >Design: This was a Phase II, before-after trial. >Setting: This study was conducted at the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL) at Tehran University of Medical Sciences in Tehran, Iran. >Participants: Fifteen patients with contact dermatitis (8 men and 7 women) between the ages of 25 and 62 years (median age: 36.4 years) were enrolled in this study. >Measurements: Changes were assessed using six skin biophysical parameters (transepidermal water loss [TEWL], stratum corneum [SC] hydration, melanin index, erythema index, skin pH, and skin friction), Physician Global Assessment (PGA) score, and Three-Item Severity (TIS) score at baseline, Week 2, and Week 4 of the study. >Results: Skin hydration and TIS showed a statistically significant improvement after treatment with study cream (p=0.023 and p=0.007, respectively). Although the reduction in TEWL was not significant, a slight decrease was observed at Week 4. >Conclusions: The skin-identical ceramide complex cream improved contact dermatitis with a decrease in TIS and an increase in skin hydration, implying a repair of the skin barrier.