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A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris

NCT01915732 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1018

Last updated 2017-02-28

Study results available
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Summary

This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects will be enrolled, 510 per study arm. The subjects will be males and females between 12 and 45 years of age, inclusive, at the time of consent, who have mild to moderate facial acne vulgaris.

Subjects will use Duac™Once Daily Gel (once daily in the evening) or clindamycin phosphate gel twice daily (once in the morning and once in the evening) for 12 weeks. The subjects will be evaluated for change in lesion counts, investigator's static global assessment (ISGA), subject's global assessment (SGA), local tolerability and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Duac™Once Daily Gel

1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide

DRUG

1% clindamycin phosphate gel

1% clindamycin as clindamycin phosphate

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • China

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 NCT01915732 on ClinicalTrials.gov