Recruiting
Phase 3

Amino Acid Cream with Desonide

Sponsor:

NeoStrata Company, Inc.

Code:

NCT02286700

Conditions

Dermatitis, Atopic

Eczema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Desonide Cream

Amino Acid Moisturizing Cream

Study Details

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 dermatitis/eczema.

Conditions

Dermatitis, Atopic

Eczema

Study ID

NCT02286700

Start date

Nov, 2014

Status verified date

Nov, 2014

Completion date

Mar, 2015

Anticipated

Primary completion date

Feb, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Desonide Group

Group randomly receiving desonide cream as the treatment cream for 3 weeks. Fifteen (15) gram tubes are dispensed at the beginning of each week and will be applied twice daily, by the subject, during the 3 week treatment phase.

experimental: Amino Acid Group

Group randomly receiving amino acid moisturizing cream as the treatment cream for 3 weeks. Fifteen (15) gram tubes are dispensed at the beginning of each week and will be applied twice daily, by the subject, during the 3 week treatment phase.

Interventions

Desonide Cream

Study cream randomized and distributed to subjects, applied twice daily for 3 weeks and evaluated ability to reduce atopic dermatitis symptoms.

Amino Acid Moisturizing Cream

Study cream randomized and distributed to subjects, applied twice daily for 3 weeks and evaluated ability to reduce atopic dermatitis symptoms.

Primary outcome measure

  • Change in skin 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. [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Locations

Mass General Hospital: Clinical Unit for Research Trials in Skin

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Alexandra B Kimball, MD

More Information

Sponsor

NeoStrata Company, Inc.

Last update posted

Nov 11, 2014

Last verified

Nov, 2014

Keywords

  • dermatitis, eczema, itch, moisturizer, amino acid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NeoStrata Company, Inc. on 2014-11-11.