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

• Status: Unknown status
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NeoStrata Company, Inc.
• Collaborator: Massachusetts General Hospital
• Treatments: Desonide

Criteria

Inclusion Criteria:

1. Male or female subjects in general good health 18 years of age or older

2. Diagnosis of atopic dermatitis will be made based on clinical criteria. Each patient must have at least one eczematous target lesion with area ranging from 10-500 cm2 of mild to moderate severity with a grade of at least 6 on the TADSI scale, plus presence of itch

3. Body surface area affected by AD lesions: ≤ 5% at start of treatment

Exclusion Criteria:

1. Pregnancy or breastfeeding

2. Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study

3. Widespread AD requiring systemic therapy

4. Diagnosis of allergic contact dermatitis

5. Known hypersensitivity to any of the constituents or excipients of the investigational product

6. Diagnosed with immunocompromised status

7. Use of systemic AD therapy, e.g. systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy in the past 1 month.

8. Use of phototherapy in the past 2 weeks

9. Use of any topical AD therapy such as corticosteroids or topical immunomodulators in the past 2 weeks

10. Use of local anti-itch or medical device treatments, e.g. benadryl, atopiclair, epiceram in the past 2 weeks

11. Use of topical moisturizers less than 24 hours in advance of the baseline visit on eczema lesions

12. Participation in another clinical research study with an investigational drug within 4 weeks before randomization in this study