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A Study To Evaluate The Contact Sensitization Potential Of Tazarotene Foam On Skin In Healthy Volunteers

NCT01114841 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2017-06-14

No results posted yet for this study

Summary

This study will assess the potential of tazarotene foam to cause sensitization during a 48 hour challenge following 21 days of exposure on the skin of healthy volunteers.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Tazarotene Foam

Patches containing Tazarotene Foam 0.1% will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours. There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge). These patches will then be evaluated at 24, 48, and 72 hours. There may be a second rest period and a second 48-hour patch application and evaluation, if required.

DRUG

Vehicle Foam

Patches containing Vehicle Foam will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours. There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge). These patches will then be evaluated at 24, 48, and 72 hours. There may be a second rest period and a second 48-hour patch application and evaluation, if required.

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
2010-03-31
Primary Completion
2010-06-26
Completion
2010-06-26

Countries

  • United States

Study Locations

More Related Trials

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 NCT01114841 on ClinicalTrials.gov