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Trial record 10 of 235 for:    clindamycin

A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615768
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Tracking Information
First Submitted Date  ICMJE July 31, 2018
First Posted Date  ICMJE August 6, 2018
Last Update Posted Date September 24, 2019
Actual Study Start Date  ICMJE August 14, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
  • Percentage Change From Baseline in Total Lesion Counts [ Time Frame: Week 12 ]
    Percent change from Baseline in total lesions counts in each treatment group at Week 12.
  • Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03615768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
  • Percentage change from baseline in inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from baseline in inflammatory lesions count in each treatment group at Week 12.
  • Percentage change from baseline in non-inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from baseline in non-inflammatory lesions count in each treatment group at Week 12.
  • Change from baseline in inflammatory lesion counts [ Time Frame: Week 12 ]
    Absolute change from baseline in inflammatory lesion counts in each treatment group at Week 12.
  • Change from baseline in non-inflammatory lesion counts [ Time Frame: Week 12 ]
    Absolute change from baseline in non-inflammatory lesion counts in each treatment group at Week 12.
  • Change from baseline in total lesion counts [ Time Frame: Week 12 ]
    Absolute change from baseline in total lesions counts in each treatment group at Week 12.
  • Change from baseline in Investigator's Global Assessment (IGA) [ Time Frame: Week 12 ]
    Absolute change from baseline in Investigator's Global Assessment (IGA) in each treatment group at Week 12.
  • Treatment success rate [ Time Frame: Week 12 ]
    The proportion of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)"; if IGA score at baseline is 2, success is only achieved if IGA score is 0 at Week 12.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 31, 2018)
Local Adverse Reactions [ Time Frame: Week 2, Week 4, Week 8 and Week 12 ]
Local Adverse Reactions including erythema, scaling, stinging, burning and pruritus scored by severity
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris
Official Title  ICMJE A Multi-center, Randomized, Single-blind, Paralelle, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Moderate Acne Vulgaris
Brief Summary This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Combination Product: Adapalene-Clindamycin Combination Gel
    5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks
  • Drug: Adapalene Gel
    Differin 0.1% Gel, applied nightly for 12 weeks
    Other Name: Differin
  • Drug: Clindamycin Gel
    Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks
    Other Name: Clindamycin
Study Arms  ICMJE
  • Experimental: Adapalene-Clindamycin Combination Gel
    Intervention: Combination Product: Adapalene-Clindamycin Combination Gel
  • Active Comparator: Adapalene Gel
    Intervention: Drug: Adapalene Gel
  • Active Comparator: Clindamycin Gel
    Intervention: Drug: Clindamycin Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2018)
1617
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, aged 12-40 years old
  • Diagnosis of Grade II-III acne vulgaris with Pillsbury grading system
  • Provide written informed consent if the subject is aged 18 or older. Ages 12-17 should provide written assent and written informed consent from patient's parent or legal guardian.

Exclusion Criteria:

  • Known hypersensitivity to adapalene, clindamycin hydrochloride, clindamycin phosphate, lincomycin or any ingredient of the study drug, or of allergic constitution
  • Secondary Acne, such as occupational acne and steroid acne
  • Has a dermatological condition of the face that could interfere with the clinical evaluations, such as sunburn, psoriasis, seborrheic dermatitis or eczema
  • History of Crohn's disease, ulcerative colitis or antibiotic-associated colitis
  • History of serious heart disease or hypertension
  • Serious liver or kidney disease, AST or ALT more than twice the upper limit of normal, or Cr above normal
  • Serious endocrine, hematologic or psychiatric disease
  • Known immunocompromised conditions, or require long-term steroids or immunosuppressants
  • Females who are pregnant, lactating, or not willing to use effective contraception
  • Drug or alcohol abuse
  • Used any topical acne treatment within 2 weeks
  • Used any systemic retinoid, antibiotic or other acne treatment
  • Used any investigational drugs or device within 3 months, or concurrently enrolled in another clinical trial
  • Patient who the investigator deemed to be unsuitable for any reason
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yu Zhu +86-15996345850 zhuyu@leespharm.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03615768
Other Study ID Numbers  ICMJE ZK-ACG-201712
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lee's Pharmaceutical Limited
Study Sponsor  ICMJE Lee's Pharmaceutical Limited
Collaborators  ICMJE Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited
Investigators  ICMJE
Principal Investigator: Heng Gu, MD Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences
PRS Account Lee's Pharmaceutical Limited
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP