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.

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.