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A Study to Evaluate the Potential of Tazarotene Foam to Cause an Allergic Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers.

NCT01119651 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2017-06-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a photoallergic reaction when exposed to UV and VIS light on skin of healthy volunteers.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Tazarotene (Patch application in Challenge Phase)

There are 2 phases in this study. The induction phase will include 6 days of patch application to the subject's back. Patches will be removed daily and irradiated. Patch applications will be placed on the same sites, unless a strong reaction is observed. The induction phase will be followed by a rest period followed by the Challenge Phase which consists of a 24-hr application of 3 sets of 3 patches (Set C, Set D, and Set E) applied to naïve sites on the subject's back. Each set of patches will consist of a tazarotene foam patch, a vehicle foam patch, and a blank patch. After 24 hrs, Set D patch sites will be evaluated and irradiated with UVA/UVB light. Set C patch sites will be evaluated and irradiated with UVA, UVB light and visible light. Set E patch sites will be evaluated \& will serve as nonirradiated controls. Patch sites will be evaluated 1 hr after patch removal and during follow up visits at 24 hrs, 48 hrs, and 72 hrs after removal of the final patch in Set E.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Stiefel, a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-14
Primary Completion
2010-06-26
Completion
2010-06-26

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01119651 on ClinicalTrials.gov