Skin Effects of a Topical Amino Acid Moisturizing Cream and Desonide in Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

Official title: A Randomized, Double-Blind, Active Control, 5 Week Study to Evaluate the Safety and Skin Effects of A New, Twice-daily, Topically Applied Amino Acid Moisturizing Cream vs. Desonide Cream in Adult Atopic Dermatitis

Status Recruiting

Clinical Trial Summary

The purpose of this study is to compare the effects of an amino acid moisturizing cream and desonide cream in reducing skin symptoms associated with AD/eczema in subjects with mild to moderate atopic dermatitis/eczema.

Clinical Trial Description

This is a double-blind, randomized study comparing the effects of an amino acid moisturizing cream and desonide cream in reducing skin symptoms associated with AD/eczema in subjects with mild to moderate atopic dermatitis/eczema. Atopic dermatitis (AD), also known as Eczema, is a chronic inflammatory skin disease that most commonly affects infants and children with a prevalence of 10-20% in children as compared to 1-3% in adults. Patients with AD have dry, irritated skin and often experience severe pruritus. Treatment of AD involves avoidance of triggers and infectious agents, cutaneous hydration, control of pruritus, and anti-inflammatory agents. Topical calcineurin inhibitors and steroids are commonly used prescription anti-inflammatory treatments. Unfortunately, there are potential side effects of long-term topical glucocorticoid use including skin atrophy, development of striae, perioral dermatitis, acne, and even hypothalamic-pituitary-adrenal axis suppression. However, many moisturizers are available without a prescription to soothe skin and reduce symptoms associated with AD/eczema via increased hydration, improved barrier function and anti-irritancy effects. The study cream being compared to desonide is a cosmetic moisturizing formulation that contains a cosmetic amino acid dipeptide (e.g., contains 2 amino acids). This study is being conducted to understand the benefits of the amino acid dipeptide moisturizing cream versus dermatologist-prescribed desonide cream in reducing the symptoms associated with AD/eczema in order to evaluate its potential use in the eczema care market. For this study, approximately 60 males and females, 18 years of age and older, who are in general good health, but diagnosed with mild to moderate AD/eczema, will be recruited, screened, and fully consented, with the goal of enrolling up to 42 evaluable subjects. The 42 Subjects (21 subjects per group) will be randomly and equally assigned to either one of 2 treatment groups of amino acid moisturizing cream or desonide cream. Neither study subjects nor study staff will be aware of the treatment assigned. The subjects will be asked to participate for approximately 5 weeks, over 5 study visits: Screening/Baseline, Weeks 1-3 (Treatment Period), Regression weeks 4 & 5. Each subject will receive one, 15 gram, blinded study cream at each treatment visit to apply twice daily at home for 3 weeks; a 2-week regression phase of no study cream will follow the treatment phase. A predetermined target lesion will be assessed at each time point via established clinical grading scales including: Target lesion Atopic Dermatitis Severity Index (TADSI), Eczema Area Severity Index (EASI), Static IGA of targeted lesion, Total IGA (PGA) and Body Surface Area involvement. All grading will be completed by the principal or sub-investigators. Photographs will also be taken at each time point to assess changes during the treatment and regression phases. Other established scales will be utilized to collect patient perception of skin effects such as: Patient-Oriented Eczema Measure (POEM), subjects' assessment of pruritus (VAS); a self-assessment questionnaire will be utilized to collect information on perceived benefits and product aesthetics. This study has been IRB approved and is scheduled to begin November of 2014 at Massachusetts General Hospital, specifically at the Clinical Unit for Research Trials in Skin (CURTIS) under principal investigator, Alexandra B. Kimball, MD. The study is being sponsored by NeoStrata Company, Inc, Princeton, NJ. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

• NCT number: NCT02286700
• Study type: Interventional
• Source: NeoStrata Company, Inc.
• Contact: Barbara A. Green, RPh
• Phone: 609-986-2971
• Email: bgreen@neostrata.com
• Status: Recruiting
• Phase: Phase 3
• Start date: November 2014
• Completion date: March 2015