Trials Sponsors Conditions Drugs Pricing

Conditions

Hand Dermatoses

Keywords

hand dermatitishand eczematriamcinolone 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) DuraPeelDrug

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

Also known as: TAC DuraPeel

Triamcinolone Acetonide (TAC) DuraPeel

Placebo DuraPeelDrug

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

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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)

Sponsors & Collaborators

ZARS Pharma Inc.
Industrylead

Study Sites (3)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Michigan Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

DermResearch Inc.

Austin, Texas, 78759, United States

MeSH Terms

Conditions

Hand Dermatoses

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

Daniel Piacquadio, MD
Therapeutics, Inc.
STUDY DIRECTOR

Enrollment

56 participants (actual enrollment reported by the registry).

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 2009

Date type not reported

This date has not been verified as actual or estimated.

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

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Triamcinolone Acetonide (TAC) DuraPeel

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Triamcinolone Acetonide (TAC) DuraPeel

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations