SAFETY AND EFFICACY OF DEWDERM AD CREAM IN PATIENTS WITH ATOPIC DERMATITIS: A 60-DAYS, PROSPECTIVE, OPEN-LABEL CLINICAL STUDY.

Dr. Muhammed Majeed, Dr. Raju Rhee, Smitha Thazhathidath, Mahesh Paschapur, Nataraj Eramuddappa, Kiran Kumar Vuppala*

ABSTRACT

Objective: To evaluate the safety and efficacy of a formulation, Dewderm AD cream, in patients with mild-to-moderate atopic dermatitis (AD). Methods: Thirty six subjects with mild-to-moderate AD aged between 5–55 years were enrolled in the study. All 36 patients were instructed to apply Dewderm AD cream twice daily on the affected area for 60 days irrespective of their visits to the clinic. Subjects underwent evaluation of efficacy parameters, such as effect of skin surface hydration and assessment of disease severity, quality of life at the end of the treatment, and photographs were taken before and after the treatment (i.e. on day 60) to assess clinical improvement of the severity of AD. Results: Treatment with Dewderm AD cream showed statistically significant improvement in all the efficacy parameters at different time points from baseline to end of the study. A statistically significant (p < 0.05) increase in mean skin surface hydration with 54.86% improvement at visit 5 was observed when compared to baseline. SCORAD score showed 80.22% reduction in the severity of skin lesions by the end of the treatment period suggesting progressive improvement in the disease severity. Similarly, the investigator‟s global assessment (IGA) scale also showed a statistically significant reduction of 67.01% from baseline 2.69 ± 0.47 to 0.88 ± 0.40 at the end of the study (p < 0.05). The DLQI score also demonstrated a statistically significant decrease (p < 0.05) from baseline to end of the study. Additionally, photograph comparing before and after treatment showed gradual clinical improvement in severity of AD of the affected area at the end of the study in subjects who had skin lesions at baseline. No adverse events were reported during the study. Conclusion: Dewderm AD cream was very effective in treating mild-to-moderate AD by significantly reducing the disease severity without any side effects. Hence, the formulation is an effective and safe treatment option in patients with mild-to-moderate AD.

Keywords: Atopic dermatitis, Investigator?s Global Assessment, Quality of Life.