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A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel

NCT00689117 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1649

Last updated 2017-05-30

Study results available
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Summary

The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.

Conditions

  • Acne Vulgaris
  • Acne

Interventions

DRUG

CT Gel

Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks

DRUG

Clindamycin Gel (clindamycin )

Clindamycin 1% gel applied topically once daily in the evening for 12 weeks

DRUG

Tretinoin Gel (tretinoin)

Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks

DRUG

Vehicle Gel

Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Stiefel, a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • United States
  • Belize
  • Canada

Study Locations

More Related Trials

Entities

Diseases
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 NCT00689117 on ClinicalTrials.gov