Safety and Efficacy Study of Triamcinolone Acetonide DuraPeel to Treat Hand Dermatitis (TAC-202)

ZARS Pharma

Status and phase

Completed

Phase 2

Conditions

Hand Dermatoses

Treatments

Drug: Triamcinolone Acetonide (TAC) DuraPeel

Drug: Placebo DuraPeel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00890968

TAC-202

Details and patient eligibility

About

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

Full 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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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