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

Hand Dermatoses Clinical Trial

— TAC-202  

Official title:

A Multi-Center Randomized, Double-Blind, Placebo Controlled, Parallel Group Comparison Study of Once Daily Triamcinolone Acetonide 0.5% DuraPeel™ Versus Placebo DuraPeel in the Treatment of Hand Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890968
• Other study ID #: TAC-202
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2009
• Last updated: March 14, 2012
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: March 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Hand Dermatoses

Intervention

Drug:
• Triamcinolone Acetonide (TAC) DuraPeel
topical gel; once daily (nightly); total duration: 4 weeks
• Placebo DuraPeel
topical gel; once daily (nightly); total duration: 4 weeks

Locations

Country	Name	City	State
United States	DermResearch Inc.	Austin	Texas
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response as assessed by Investigator Global Assessment (IGA)		Baseline, Week 1, Week 2, Week 4	No
Secondary	Subject's Global Impression of Change (SGIC)		Week 4 (end-of-treatment)	No
Secondary	Individual Primary Parameters of Hand Dermatitis		Baseline, Week 1, Week 2, Week 4	No
Secondary	Signs or symptoms of hand dermatitis		Baseline, Week 1, Week 2, Week 4	No
Secondary	Subject's self-assessment of overall hand disease		Baseline, Week 4	No
Secondary	Study medication assessment		Week 1, Week 2, Week 4	No