Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids Versus Low-Potency Corticosteroid Mono-therapy

This study has been withdrawn prior to enrollment.
(Funding withdrawn)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00871208
First received: March 27, 2009
Last updated: June 29, 2010
Last verified: June 2010
  Purpose

This study is designed to determine whether the addition of topical Altabax (R) to a treatment regimen of topical corticosteroid therapy speeds clearance of atopic dermatitis and improves quality of life.


Condition Intervention Phase
Atopic Dermatitis
Drug: Altabax (R)
Drug: Vehicle and Locoid lipocream (R)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids vs. Low-Potency Corticosteroid Mono-therapy

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Superiority of drug to vehicle in reducing Eczema Area and Severity Index (EASI) scores in children with atopic dermatitis [ Time Frame: Each patient will be enrolled for a 4 week trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved quality of life with usage of the drug altabax (R) and topical corticosteroids over vehicle and topical corticosteroids for treatment of atopic dermatitis in children with atopic dermatitis. [ Time Frame: 4 week trial of medication ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Altabax (R) and Locoid Lipocream (R):Patients will apply both drugs sequentially to active lesions of atopic dermatitis. Physical examination, skin cultures, photos and quality of life scores will be performed at baseline, week 1, week 2 and week 4.
Drug: Altabax (R)
Retapamulin 1% ointment is to be applied to lesional atopic dermatitis twice-daily in addition to a topical corticosteroid (Locoid lipocream (R))
Other Names:
  • Altabax(R)ointment
  • Locoid lipocream (R)
Active Comparator: 2
Vehicle and Locoid Lipocream (R):Patients will apply both drugs sequentially to active lesions of atopic dermatitis. Physical examination, skin cultures, photos and quality of life scores will be performed at baseline, week 1, week 2 and week 4.
Drug: Vehicle and Locoid lipocream (R)
The vehicle base of retapamulin ointment will be applied twice-daily to active lesions of atopic dermatitis in addition to locoid lipocream (R)
Other Name: Locoid lipocream (R)

Detailed Description:

Background: Atopic dermatitis is a pruritic skin disorder which affects more than 10% of the United States population, one-third of whom report sleep disturbance and a quarter with chronic unremitting disease. Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and extensive costs for the health care system. Quality of life is often impaired for patients with atopic dermatitis due to sleep disturbance, pruritus and the physical impairment of visible skin lesions.

The rapidity in which pruritus and lesional appearance are noted to resolve correlates strongly with improved patient satisfaction and improved quality of life.

Recently, a clinical trial of adding mupirocin into a regimen of topical corticosteroids has shown a significant enhancement in lesional clearance and symptom reduction with addition of mupirocin to the topical corticosteroid. These improvements were most notable within the first week of treatment.

Proposal: A 4-week clinical trial of 60 atopic dermatitis patients (ages 9 months to 17 years) would be conducted. All sixty patients would be given topical mid-potency corticosteroid (Locoid lipocream®) to be mixed with a second product. Half the patients would receive Altabax® and the other half would receive vehicle (blinded to subject and investigator). Patients would be advised to apply the topical randomized product first, let dry and then apply topical Locoid lipocream ® to affected areas, and then apply the topical randomized ointment product to each of the sites of skin disease on top of the Locoid lipocream ®. Treatment of affected areas would continue for 4 weeks or until lesions have cleared, which ever comes first. Parents of patients will be asked to maintain a written diary of drug application.

  Eligibility

Ages Eligible for Study:   9 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Diagnosis of Atopic Dermatitis
  2. Ages 9 months to 17 years
  3. Presence of at least one lesion of atopic dermatitis at the time of baseline enrollment
  4. Disease limited to less than 100 cm2 body surface area
  5. EASI Score of at least 7, based on the Gong, et al publication Gong JQ, Lin L, Lin T, Hao F, Zeng FQ, Bi ZG, Yi D, Zhao B. Skin colonization by Staphylococcus aureus in patients with eczema and atopic dermatitis and relevant combined topical therapy: a double-blind multicentre randomized controlled trial. Br J Dermatol. 2006 Oct;155(4):680-7.

Exclusion Criteria:

  1. Allergy to any ingredient in Altabax® or Locoid lipocream ®
  2. Usage of oral corticosteroids within the 2 weeks prior to study initiation or during the study
  3. Usage of topical corticosteroid or other topical prescriptions for atopic dermatitis in the week prior to study initiation
  4. Inability to comply with the study protocol
  5. Presence of major medical illness requiring systemic therapy including cancers.
  6. Clinical diagnosis of bacterial infections of the skin, including impetigo or abscesses.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871208

Locations
United States, New York
Department of Dermatology, St. Luke's-Roosevelt-Hospital Center
NY, New York, United States, 10025
Department of Dermatology, Roosevelt Hospital
NY, New York, United States, 10019
Department of Dermatology, Beth Israel Medical Center
NY, New York, United States, 10003
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
GlaxoSmithKline
  More Information

Publications:
Responsible Party: Nanette Silverberg, MD, St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00871208     History of Changes
Other Study ID Numbers: SLR08-057-111672
Study First Received: March 27, 2009
Last Updated: June 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Atopic Dermatitis
pruritus
quality of life

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on September 22, 2014