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

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ClinicalTrials.gov Identifier: NCT02286700
Recruitment Status : Unknown
Verified November 2014 by NeoStrata Company, Inc..
Recruitment status was:  Recruiting
First Posted : November 10, 2014
Last Update Posted : November 11, 2014
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
NeoStrata Company, Inc.

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Eczema Drug: Desonide Cream Other: Amino Acid Moisturizing Cream Phase 3

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 moderate atopic dermatitis/eczema. Atopic dermatitis (AD), also known as Eczema, is a chronic inflammatory skin disease that most commonly affects infants and children with a prevalence of 10-20% in children as compared to 1-3% in adults. Patients with AD have dry, irritated skin and often experience severe pruritus. Treatment of AD involves avoidance of triggers and infectious agents, cutaneous hydration, control of pruritus, and anti-inflammatory agents. Topical calcineurin inhibitors and steroids are commonly used prescription anti-inflammatory treatments. Unfortunately, there are potential side effects of long-term topical glucocorticoid use including skin atrophy, development of striae, perioral dermatitis, acne, and even hypothalamic-pituitary-adrenal axis suppression. However, many moisturizers are available without a prescription to soothe skin and reduce symptoms associated with AD/eczema via increased hydration, improved barrier function and anti-irritancy effects. The study cream being compared to desonide is a cosmetic moisturizing formulation that contains a cosmetic amino acid dipeptide (e.g., contains 2 amino acids). This study is being conducted to understand the benefits of the amino acid dipeptide moisturizing cream versus dermatologist-prescribed desonide cream in reducing the symptoms associated with AD/eczema in order to evaluate its potential use in the eczema care market. For this study, approximately 60 males and females, 18 years of age and older, who are in general good health, but diagnosed with mild to moderate AD/eczema, will be recruited, screened, and fully consented, with the goal of enrolling up to 42 evaluable subjects. The 42 Subjects (21 subjects per group) will be randomly and equally assigned to either one of 2 treatment groups of amino acid moisturizing cream or desonide cream. Neither study subjects nor study staff will be aware of the treatment assigned. The subjects will be asked to participate for approximately 5 weeks, over 5 study visits: Screening/Baseline, Weeks 1-3 (Treatment Period), Regression weeks 4 & 5. Each subject will receive one, 15 gram, blinded study cream at each treatment visit to apply twice daily at home for 3 weeks; a 2-week regression phase of no study cream will follow the treatment phase. A predetermined target lesion will be assessed at each time point via established clinical grading scales including: Target lesion Atopic Dermatitis Severity Index (TADSI), Eczema Area Severity Index (EASI), Static IGA of targeted lesion, Total IGA (PGA) and Body Surface Area involvement. All grading will be completed by the principal or sub-investigators. Photographs will also be taken at each time point to assess changes during the treatment and regression phases. Other established scales will be utilized to collect patient perception of skin effects such as: Patient-Oriented Eczema Measure (POEM), subjects' assessment of pruritus (VAS); a self-assessment questionnaire will be utilized to collect information on perceived benefits and product aesthetics. This study has been IRB approved and is scheduled to begin November of 2014 at Massachusetts General Hospital, specifically at the Clinical Unit for Research Trials in Skin (CURTIS) under principal investigator, Alexandra B. Kimball, MD. The study is being sponsored by NeoStrata Company, Inc, Princeton, NJ.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Active Control, 5 Week Study to Evaluate the Safety and Skin Effects of A New, Twice-daily, Topically Applied Amino Acid Moisturizing Cream vs. Desonide Cream in Adult Atopic Dermatitis
Study Start Date : November 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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.
Drug: Desonide Cream
Study cream randomized and distributed to subjects, applied twice daily for 3 weeks and evaluated ability to reduce atopic dermatitis symptoms.
Other Name: Desonide Cream 0.05%

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.
Other: 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 Measures :
  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. [ Time Frame: 5 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286700


Contacts
Contact: Barbara A. Green, RPh 609-986-2971 bgreen@neostrata.com
Contact: Justine K. Gostomski, MS 609-986-2969 jgostomski@neostrata.com

Locations
United States, Massachusetts
Mass General Hospital: Clinical Unit for Research Trials in Skin Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lynne Hermosilla    617-725-5066    harvardskinstudies@partners.org   
Principal Investigator: Alexandra B Kimball, MD         
Sponsors and Collaborators
NeoStrata Company, Inc.
Massachusetts General Hospital
Investigators
Principal Investigator: Alexandra Kimball, MD Massachusetts General Hospital: Clinical Unit for Research Trials in Skin

Publications:
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.

Responsible Party: NeoStrata Company, Inc.
ClinicalTrials.gov Identifier: NCT02286700     History of Changes
Other Study ID Numbers: 14-ECD108
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: November 11, 2014
Last Verified: November 2014

Keywords provided by NeoStrata Company, Inc.:
dermatitis, eczema, itch, moisturizer, amino acid

Additional relevant MeSH terms:
Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desonide
Anti-Inflammatory Agents