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

NCT ID: NCT00890968

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-08-31

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.

Conditions

Hand Dermatoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Triamcinolone Acetonide (TAC) DuraPeel

Group Type: EXPERIMENTAL

Triamcinolone Acetonide (TAC) DuraPeel

Intervention Type: DRUG

topical gel; once daily (nightly); total duration: 4 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo DuraPeel

Intervention Type: DRUG

topical gel; once daily (nightly); total duration: 4 weeks

Interventions

Triamcinolone Acetonide (TAC) DuraPeel

topical gel; once daily (nightly); total duration: 4 weeks

Intervention Type: DRUG

Placebo DuraPeel

topical gel; once daily (nightly); total duration: 4 weeks

Intervention Type: DRUG

Other Intervention Names

TAC DuraPeel

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZARS Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Piacquadio, MD

Role: STUDY_DIRECTOR

Therapeutics, Inc.

Locations

Therapeutics Clinical Research

San Diego, California, United States

Michigan Center for Skin Care Research

Clinton Township, Michigan, United States

DermResearch Inc.

Austin, Texas, United States

Countries

United States

Other Identifiers

TAC-202

Identifier Type: -

Identifier Source: org_study_id