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
  Purpose

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


Condition Intervention Phase
Hand Dermatoses
Drug: Triamcinolone Acetonide (TAC) DuraPeel
Drug: Placebo DuraPeel
Phase 2

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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • Response as assessed by Investigator Global Assessment (IGA) [ Time Frame: Baseline, Week 1, Week 2, Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 56
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triamcinolone Acetonide (TAC) DuraPeel Drug: Triamcinolone Acetonide (TAC) DuraPeel
topical gel; once daily (nightly); total duration: 4 weeks
Other Name: TAC DuraPeel
Placebo Comparator: Placebo Drug: Placebo DuraPeel
topical gel; once daily (nightly); total duration: 4 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890968

Locations
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Michigan
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States, 48038
United States, Texas
DermResearch Inc.
Austin, Texas, United States, 78759
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Study Director: Daniel Piacquadio, MD Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00890968     History of Changes
Other Study ID Numbers: TAC-202
Study First Received: April 28, 2009
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
hand dermatitis
hand eczema
triamcinolone acetonide

Additional relevant MeSH terms:
Dermatitis
Hand Dermatoses
Skin Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014