Status:
UNKNOWN
Skin Effects of a Topical Amino Acid Moisturizing Cream and Desonide in Atopic Dermatitis
Lead Sponsor:
NeoStrata Company, Inc.
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Dermatitis, Atopic
Eczema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed 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 moder...
Eligibility Criteria
Inclusion
- Male or female subjects in general good health 18 years of age or older
- 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
- Body surface area affected by AD lesions: ≤ 5% at start of treatment
Exclusion
- Pregnancy or breastfeeding
- 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
- Widespread AD requiring systemic therapy
- Diagnosis of allergic contact dermatitis
- Known hypersensitivity to any of the constituents or excipients of the investigational product
- Diagnosed with immunocompromised status
- Use of systemic AD therapy, e.g. systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy in the past 1 month.
- Use of phototherapy in the past 2 weeks
- Use of any topical AD therapy such as corticosteroids or topical immunomodulators in the past 2 weeks
- Use of local anti-itch or medical device treatments, e.g. benadryl, atopiclair, epiceram in the past 2 weeks
- Use of topical moisturizers less than 24 hours in advance of the baseline visit on eczema lesions
- Participation in another clinical research study with an investigational drug within 4 weeks before randomization in this study
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02286700
Start Date
November 1 2014
End Date
March 1 2015
Last Update
November 11 2014
Active Locations (1)
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1
Mass General Hospital: Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States, 02114