Ignite Creation Date:
2024-05-06 @ 7:32 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02557399
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2015-06-11
Brief Title:
DUAC Early Onset Efficacy Study in Japanese Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Clinical Evaluation of Efficacy at 2 Weeks of Duac Fixed Dose Combination Gel in Treatment of Facial Acne Vulgaris in Japanese Subjects
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 01 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 01 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None