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

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

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

Study Overview

• Status: Completed
• Conditions: Hand Dermatoses
• Intervention / Treatment: Drug: Triamcinolone Acetonide (TAC) DuraPeel; Drug: Placebo DuraPeel

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Skin Care Research
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo DuraPeel; topical gel; once daily (nightly); total duration: 4 weeks
Experimental: Triamcinolone Acetonide (TAC) DuraPeel	Drug: Triamcinolone Acetonide (TAC) DuraPeel; topical gel; once daily (nightly); total duration: 4 weeks; Other Names: TAC DuraPeel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response as assessed by Investigator Global Assessment (IGA)	Baseline, Week 1, Week 2, Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: ZARS Pharma Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: April 28, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimate): April 30, 2009

Study Record Updates

• Last Update Posted (Estimate): March 16, 2012
• Last Update Submitted That Met QC Criteria: March 14, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: hand eczema; triamcinolone acetonide; hand dermatitis
• Additional Relevant MeSH Terms: Dermatitis; Skin Diseases; Hand Dermatoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: TAC-202