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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00890968
First received: April 28, 2009
Last updated: March 14, 2012
Last verified: March 2012

April 28, 2009
March 14, 2012
April 2009
June 2009   (final data collection date for primary outcome measure)
Response as assessed by Investigator Global Assessment (IGA) [ Time Frame: Baseline, Week 1, Week 2, Week 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00890968 on ClinicalTrials.gov Archive Site
  • Subject's Global Impression of Change (SGIC) [ Time Frame: Week 4 (end-of-treatment) ] [ Designated as safety issue: No ]
  • Individual Primary Parameters of Hand Dermatitis [ Time Frame: Baseline, Week 1, Week 2, Week 4 ] [ Designated as safety issue: No ]
  • Signs or symptoms of hand dermatitis [ Time Frame: Baseline, Week 1, Week 2, Week 4 ] [ Designated as safety issue: No ]
  • Subject's self-assessment of overall hand disease [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
  • Study medication assessment [ Time Frame: Week 1, Week 2, Week 4 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Triamcinolone Acetonide DuraPeel to Treat Hand Dermatitis
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hand Dermatoses
  • Drug: Triamcinolone Acetonide (TAC) DuraPeel
    topical gel; once daily (nightly); total duration: 4 weeks
    Other Name: TAC DuraPeel
  • Drug: Placebo DuraPeel
    topical gel; once daily (nightly); total duration: 4 weeks
  • Experimental: Triamcinolone Acetonide (TAC) DuraPeel
    Intervention: Drug: Triamcinolone Acetonide (TAC) DuraPeel
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo DuraPeel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
August 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00890968
TAC-202
No
ZARS Pharma Inc.
ZARS Pharma Inc.
Not Provided
Study Director: Daniel Piacquadio, MD Therapeutics, Inc.
ZARS Pharma Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP