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

Status unconfirmed · Phase 3

Conditions studied: Dermatitis, Atopic, Eczema

In brief

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.

Key facts

Study ID

NCT02286700

Run by

NeoStrata Company, Inc.

People needed

42

Starts

2014-11-01

Expected to finish

2015-03-01

Last updated by the study team

2014-11-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mass General Hospital: Clinical Unit for Research Trials in Skin — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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