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DUAC® Early Onset Efficacy Study in Japanese Subjects

NCT02557399 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2018-08-20

Study results available
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Summary

This is a multicentre, randomized, single-blind (investigator is blinded), active (the combination therapy of adapalene \[ADA\] and clindamycin \[CLDM\])-controlled and parallel-group study in Japanese subjects with facial acne vulgaris. The purpose of this study is to evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3% (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Duac® fixed dose combination gel

Duac® fixed dose combination gel containing clindamycin phosphate 1.2% and benzoyl peroxide 3%.

DRUG

ADA 0.1% gel

ADA 0.1% gel containing 0.1% of adapalene.

DRUG

CLDM 1% gel

CLDM 1% gel containing clindamycin phosphate 1.2% (1% as clindamycin).

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
2015-10-07
Primary Completion
2015-12-17
Completion
2016-02-17

Countries

  • Japan

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 NCT02557399 on ClinicalTrials.gov