Safety and Efficacy Study of Triamcinolone Acetonide DuraPeel to Treat Hand Dermatitis

Phase 2

Completed

• Conditions: Hand Dermatoses
• Interventions: Drug: Triamcinolone Acetonide (TAC) DuraPeel; Drug: Placebo DuraPeel

• Registration Number: NCT00890968
• Lead Sponsor: ZARS Pharma Inc.

Brief Summary

The purpose of this study is to determine whether Triamcinolone Acetonide (TAC) DuraPeel is safe and effective in the treatment of hand dermatitis.

Detailed Description

Triamcinolone acetonide is a commonly used, safe, and effective topical corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. However, the effectiveness of topical agents such as creams or ointments is limited by patients' routine activities using bare hands that may remove the topical agent from the hands. The use of a topical corticosteroid in a vehicle that allows the product to remain in contact with the skin and is not susceptible to inadvertent removal would be beneficial.

The DuraPeel membrane is expected to optimize exposure to the steroid by remaining on the treatment area for a prolonged period of time.

This study is designed to evaluate the efficacy and safety of Triamcinolone Acetonide 0.5% DuraPeel. Eligible subjects will receive Triamcinolone Acetonide 0.5% DuraPeel or Placebo DuraPeel. The study duration will be approximately 4 weeks.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-30
• Primary Completion: 2009-06
• Study Completion: 2009-08
• Status Verified: 2012-03
• Disposition First Submitted: 2012-03-14
• Disposition First Submitted QC: 2012-03-14
• Last Update Submitted: 2012-03-14
• Disposition First Posted: 2012-03-16
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Clinical diagnosis of stable chronic hand dermatitis (greater than 6 weeks duration) that is KOH-negative
• Dermatitis of mild to moderate severity, as defined by an Investigator's Global Assessment (a score of 2 or 3 on the Target Hand)
• Individual signs of hand dermatitis disease of at least mild scaling and mild erythema (a score of 2 or more on the Target Hand)
• Written informed consent

Exclusion Criteria

• Subject is female and is pregnant, lactating, or is planning to become pregnant during the study
• Spontaneously improving or rapidly deteriorating hand dermatitis at the time of enrollment; subject may have history of waxing and waning disease in the past
• History of hand dermatitis that has been shown to be unresponsive to super potent (Group 1) topical steroids
• Concurrent flaring of inflammatory skin disease (e.g., atopic dermatitis or psoriasis) anywhere on the body outside the study areas
• Bullous disorders or hand, foot, and mouth disease (HFMD); however, subjects with dyshidrotic hand dermatitis or pompholyx are allowed to participate provided they meet all other Inclusion/Exclusion criteria
• Known allergic mediated hand dermatitis (e.g., allergic to latex, etc.)
• Concurrent skin diseases in the study area that require concomitant topical treatment (e.g., tinea manuum, scabies, infected eczema, and paronychia) that could interfere with the evaluation of his/her dermatitis
• Pustular diseases of the hands (e.g., acrodermatitis perstans continua).
• Used photo-therapy, photo-chemotherapy, systemic immunomodulatory therapy (such as systemic corticosteroids, methotrexate, retinoids or cyclosporine), or other therapy within 30 days prior to the first application of study medication that is known or suspected, in the opinion of the investigator, to have an effect on hand dermatitis
• Prolonged exposure to natural or artificial sources (e.g., UVB, UVA, etc.) of ultraviolet radiation within 30 days prior to the first application of study medication or is intending to have such exposure during the study
• Received intralesional therapy to the hands (e.g., corticosteroids) within 30 days prior to first application of study medication
• Treated with Grenz ray or soft x-ray therapy to the hands within 6 months of first application of study medication
• Treated with topical hand therapy (e.g., tar, topical corticosteroids, topical retinoids, topical antimicrobials, topical calcineurin inhibitors, Burrow's solution soaks) within 7 days prior to first application of study medication that is known or suspected to have an effect on hand dermatitis
• Received systemic antibiotics for infections of the hands within 7 days prior to the first application of study medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triamcinolone Acetonide (TAC) DuraPeel	Triamcinolone Acetonide (TAC) DuraPeel	-
Placebo	Placebo DuraPeel	-

Primary Outcome Measures

Name	Time	Method
Response as assessed by Investigator Global Assessment (IGA)	Baseline, Week 1, Week 2, Week 4

Secondary Outcome Measures

Name	Time	Method
Subject's Global Impression of Change (SGIC)	Week 4 (end-of-treatment)
Individual Primary Parameters of Hand Dermatitis	Baseline, Week 1, Week 2, Week 4
Signs or symptoms of hand dermatitis	Baseline, Week 1, Week 2, Week 4
Subject's self-assessment of overall hand disease	Baseline, Week 4
Study medication assessment	Week 1, Week 2, Week 4

Trial Locations

Locations (3)

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

DermResearch Inc.; 🇺🇸 Austin, Texas, United States

Michigan Center for Skin Care Research; 🇺🇸 Clinton Township, Michigan, United States