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

NCT00890968 | Completed Phase 2

• 1 other identifier: TAC-202
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

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.

Conditions

Hand Dermatoses

Keywords

hand dermatitis; hand eczema; triamcinolone acetonide

Outcome Measures

Primary Outcomes (1)

• Response as assessed by Investigator Global Assessment (IGA)

  Baseline, Week 1, Week 2, Week 4

Secondary Outcomes (5)

• 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

Study Arms (2)

Triamcinolone Acetonide (TAC) DuraPeel

EXPERIMENTAL

Drug: Triamcinolone Acetonide (TAC) DuraPeel

Placebo

PLACEBO COMPARATOR

Drug: Placebo DuraPeel

Interventions

Triamcinolone Acetonide (TAC) DuraPeel DRUG

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

Also known as: TAC DuraPeel

Triamcinolone Acetonide (TAC) DuraPeel

Placebo DuraPeel DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ZARS Pharma Inc.: lead

Study Sites (3)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Michigan Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

Location

DermResearch Inc.

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Hand Dermatoses

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Daniel Piacquadio, MD

  Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 30, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

US (3)