NCT02557399

DUAC® Early Onset Efficacy Study in Japanese Subjects

Clinical Evaluation of Efficacy at 2 Weeks of Duac® Fixed Dose Combination Gel in Treatment of Facial Acne Vulgaris in Japanese Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Duac® is a registered trademark of Stiefel Laboratories, Inc., a GSK company. Duac® marketed in Japan is CLDM 1%-benzoyl peroxide 3% combination gel.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-10-07
• Primary completion: 2015-12-17
• Completion: 2016-02-17
• First posted: 2015-09-23
• Last updated: 2018-08-20
• Results posted: 2018-02-15

Locations

15 sites across 1 country: Japan