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

NCT02286700 | Unknown Phase 3

• 1 other identifier: 14-ECD108
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

dermatitis, eczema, itch, moisturizer, amino acid

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in erythema, pruritus, exudation, excoriation and Lichenification from baseline of atopic dermatitis target lesions after application of either amino acid moisturizing cream or desonide cream twice daily for three weeks.

  5 weeks

Study Arms (2)

Desonide Group

ACTIVE COMPARATOR

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.

Drug: Desonide Cream

Amino Acid Group

EXPERIMENTAL

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.

Other: Amino Acid Moisturizing Cream

Interventions

Desonide Cream DRUG

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

Also known as: Desonide Cream 0.05%

Desonide Group

Amino Acid Moisturizing Cream OTHER

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

Amino Acid Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• NeoStrata Company, Inc.: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Mass General Hospital: Clinical Unit for Research Trials in Skin

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (5)

• Leung DM, Eichenfield LF, Boguniewicz M. Chapter 14. Atopic Dermatitis (Atopic Eczema). In: Goldsmith LA, Katz SI, Gilchrest BA, Paller AS, Leffell DJ, Wolff K. eds. Fitzpatrick's Dermatology in General Medicine, 8e. New York, NY: McGraw-Hill; 2012. http://accessmedicine.mhmedical.com/content.aspx?bookid=392&Sectionid=41138709. Accessed July 03, 2014.

  BACKGROUND

• Elias PM, Steinhoff M. "Outside-to-inside" (and now back to "outside") pathogenic mechanisms in atopic dermatitis. J Invest Dermatol. 2008 May;128(5):1067-70. doi: 10.1038/jid.2008.88.

  PMID: 18408746 BACKGROUND

• Williams HC. Clinical practice. Atopic dermatitis. N Engl J Med. 2005 Jun 2;352(22):2314-24. doi: 10.1056/NEJMcp042803. No abstract available.

  PMID: 15930422 BACKGROUND

• Rudikoff D, Lebwohl M. Atopic dermatitis. Lancet. 1998 Jun 6;351(9117):1715-21. doi: 10.1016/S0140-6736(97)12082-7. No abstract available.

  PMID: 9734903 BACKGROUND

• Langan SM, Williams HC. What causes worsening of eczema? A systematic review. Br J Dermatol. 2006 Sep;155(3):504-14. doi: 10.1111/j.1365-2133.2006.07381.x.

  PMID: 16911274 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Dermatitis; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra Kimball, MD

  Massachusetts General Hospital: Clinical Unit for Research Trials in Skin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara A. Green, RPh

CONTACT

609-986-2971; bgreen@neostrata.com

Justine K. Gostomski, MS

CONTACT

609-986-2969; jgostomski@neostrata.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 10, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 11, 2014

Record last verified: 2014-11

Locations

US (1)