Last updated: 11/07/2018 07:50:44

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

GSK study ID
114543
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Multicentre, Randomized, Assessor-blind, Comparator-Controlled, Parallel-Group Clinical Trial to Establish the Efficacy and Safety of Duac™(1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide) Once Daily Gel Compared with Clindamycin Phosphate gel (1% clindamycin as clindamycin phosphate) twice daily in the Treatment of Mild to Moderate Acne Vulgaris.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Absolute change in total lesion count from Baseline to Week 12

Timeframe: Baseline (Week 0) and Week 12

Absolute change in total lesion count from Baseline to Week 12

Timeframe: Baseline (Week 0) and Week 12

Number of participants with an improvement of 2 grades in the Investigator Static Global Assessment (ISGA) score from Baseline to Week 12

Timeframe: Baseline (Week 0) and Week 12

Number of participants with an improvement of 2 grades in the Investigator Static Global Assessment (ISGA) score from Baseline to Week 12

Timeframe: Baseline (Week 0) and Week 12

Secondary outcomes:

Absolute change in inflammatory lesion counts and non-inflammatory lesion counts from Baseline to Week 12

Timeframe: Baseline (Week 0) and Week 12

Absolute change in inflammatory lesion counts and non-inflammatory lesion counts from Baseline to Week 12

Timeframe: Baseline (Week 0) and Week 12

Percent change in inflammatory, non-inflammatory and total lesion counts from Baseline to Week 12

Timeframe: Baseline (Week 0) and Week 12

Percent change in inflammatory, non-inflammatory and total lesion counts from Baseline to Week 12

Timeframe: Baseline (Week 0) and Week 12

Number of participants who had an ISGA score of 0 or 1 at Week 12

Timeframe: Week 12

Number of participants who had an ISGA score of 0 or 1 at Week 12

Timeframe: Week 12

Interventions:
Drug: Duac™Once Daily Gel
Drug: 1% clindamycin phosphate gel
Enrollment:
1018
Observational study model:
Not applicable
Primary completion date:
2014-20-04
Time perspective:
Not applicable
Clinical publications:
Xu J, Lu Q, Huang J, Hao F, Sun Q, Fang H, Gu J, Dong X, Zheng J, Luo D, Li F, Wang G, Gu H, Tian H, Yang H, Xi L, Li M, Zheng M, Wu Y, Tu Y, He Y, Zhao G, Sheng W, Li J, Hamedani A. A multicenter, randomized, single-blind comparison of topical clindamycin 1%/benzoyl peroxide 5% once-daily gel versus clindamycin 1% twice-daily gel in the treatment of mild to moderate acne vulgaris in Chinese patients. J Eur Acad Dermatol Venereol. 2016;30(7):1176-82.
Medical condition
Acne Vulgaris
Product
benzoyl peroxide, benzoyl peroxide/clindamycin phosphate, clindamycin phosphate
Collaborators
Not applicable
Study date(s)
April 2013 to April 2014
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
12 - 45 years
Accepts healthy volunteers
No
  • 1. Male and female subjects between 12 and 45 years of age, inclusive age will be calculated by date of birth, from 0 at birth.
  • 2. Subjects who have:
  • 1. Female subjects who are pregnant, trying to become pregnant, or who are lactating.
  • 2. Subjects who have cystic acne lesions, acne conglobata, acne fulminans, or secondary acne (e.g. chloracne or drug-induced acne).

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Shanghai, China, 200040
Status
Study Complete
Location
GSK Investigational Site
Guangzhou, Guangdong, China, 510080
Status
Study Complete
Location
GSK Investigational Site
Changsha, Hunan, China, 410011
Status
Study Complete
Location
GSK Investigational Site
Beijing, China, 100034
Status
Study Complete
Location
GSK Investigational Site
Nanjing, Jiangsu, China, 210029
Status
Study Complete
Location
GSK Investigational Site
Wuhan, China, 430022
Status
Study Complete
Location
GSK Investigational Site
Beijing, China, 100036
Status
Study Complete
Location
GSK Investigational Site
Beijing, China, 100730
Status
Study Complete
Location
GSK Investigational Site
Nanjing, Jiangsu, China, 210042
Status
Study Complete
Location
GSK Investigational Site
Shanghai, China, 200092
Status
Study Complete
Location
GSK Investigational Site
Wuhan, Hebei, China, 430071
Status
Study Complete
Location
GSK Investigational Site
Changsha, Hunan, China, 410013
Status
Study Complete
Location
GSK Investigational Site
Shanghai, China, 200433
Status
Study Complete
Location
GSK Investigational Site
Guangzhou, Guangdong, China, 510010
Status
Study Complete
Location
GSK Investigational Site
Hangzhou, Zhejiang, China, 310009
Status
Study Complete
Location
GSK Investigational Site
Chongqing, China, 400038
Status
Study Complete
Location
GSK Investigational Site
Changchun, Jilin, China, 130041
Status
Study Complete
Location
GSK Investigational Site
Guangzhou, Guangdong, China, 510120
Status
Study Complete
Location
GSK Investigational Site
Beijing, China, 100020
Status
Study Complete
Location
GSK Investigational Site
Hangzhou, Zhejiang, China, 310003
Status
Study Complete
Location
GSK Investigational Site
Shanghai, China, 200025
Status
Study Complete
Location
GSK Investigational Site
Xian, Shanxi, China, 710032
Status
Study Complete
Location
GSK Investigational Site
Shanghai, China, 200032
Status
Study Complete
Location
GSK Investigational Site
Jinan, Shandong, China, 250022
Status
Study Complete

Study documents

Scientific result summary
Available language(s): English
Protocol
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2014-20-04
Actual study completion date
2014-20-04

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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