DUAC® Early Onset Efficacy Study in Japanese Subjects

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Acne Vulgaris

Clinical Trial Details

NCT number	NCT02557399
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 4
Start date	October 7, 2015
Completion date	February 17, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04321070` - Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris	Phase 1
Recruiting	`NCT05755256` - The Impact of Probiotics on Skin Hydration in Youth With Mild Acne	Phase 2
Completed	`NCT05131373` - Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris	Phase 1
Completed	`NCT01445301` - Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects	Phase 3
Completed	`NCT03303170` - Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris	N/A
Completed	`NCT04698239` - Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions.	N/A
Completed	`NCT02886715` - A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris	Phase 3
Terminated	`NCT02924428` - Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris	N/A
Not yet recruiting	`NCT02491060` - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris	Phase 3
Not yet recruiting	`NCT02525822` - Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris	Phase 2
Not yet recruiting	`NCT02535871` - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris	Phase 3
Completed	`NCT02709902` - Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris	Phase 1
Completed	`NCT02250430` - A Phase 1 Study Assessing Local Cutaneous Effects of SB204	Phase 1
Completed	`NCT02913001` - The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne	N/A
Completed	`NCT01694810` - Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers	Phase 1
Completed	`NCT01769664` - A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris	Phase 1
Completed	`NCT01727440` - Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment	N/A
Completed	`NCT01194375` - A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris	Phase 2
Completed	`NCT01706250` - U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™	Phase 4
Completed	`NCT02524665` - 8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne	Phase 4