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
Study complete
Study complete
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
    Primary completion date:
    2014-20-04
    Observational study model:
    Not applicable
    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
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    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
    Study complete
    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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