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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Adapalene-Clindamycin Combination Gel
Adapalene Gel
Clindamycin Gel
Sponsored by
Lee's Pharmaceutical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Adapalene-Clindamycin Combination Gel

Adapalene Gel

Clindamycin Gel

Arm Description

Outcomes

Primary Outcome Measures

Percentage Change From Baseline in Total Lesion Counts
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

Secondary Outcome Measures

Percentage change from baseline in inflammatory lesion counts
Percent change from baseline in inflammatory lesions count in each treatment group at Week 12.
Percentage change from baseline in non-inflammatory lesion counts
Percent change from baseline in non-inflammatory lesions count in each treatment group at Week 12.
Change from baseline in inflammatory lesion counts
Absolute change from baseline in inflammatory lesion counts in each treatment group at Week 12.
Change from baseline in non-inflammatory lesion counts
Absolute change from baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Change from baseline in total lesion counts
Absolute change from baseline in total lesions counts in each treatment group at Week 12.
Change from baseline in Investigator's Global Assessment (IGA)
Absolute change from baseline in Investigator's Global Assessment (IGA) in each treatment group at Week 12.
Treatment success rate
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.

Full Information

First Posted
July 31, 2018
Last Updated
April 27, 2020
Sponsor
Lee's Pharmaceutical Limited
Collaborators
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03615768
Brief Title
A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
February 13, 2020 (Actual)
Study Completion Date
April 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited
Collaborators
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1617 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapalene-Clindamycin Combination Gel
Arm Type
Experimental
Arm Title
Adapalene Gel
Arm Type
Active Comparator
Arm Title
Clindamycin Gel
Arm Type
Active Comparator
Intervention Type
Combination Product
Intervention Name(s)
Adapalene-Clindamycin Combination Gel
Intervention Description
5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Adapalene Gel
Other Intervention Name(s)
Differin
Intervention Description
Differin 0.1% Gel, applied nightly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Clindamycin Gel
Other Intervention Name(s)
Clindamycin
Intervention Description
Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Percentage Change From Baseline in Total Lesion Counts
Description
Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Time Frame
Week 12
Title
Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage change from baseline in inflammatory lesion counts
Description
Percent change from baseline in inflammatory lesions count in each treatment group at Week 12.
Time Frame
Week 12
Title
Percentage change from baseline in non-inflammatory lesion counts
Description
Percent change from baseline in non-inflammatory lesions count in each treatment group at Week 12.
Time Frame
Week 12
Title
Change from baseline in inflammatory lesion counts
Description
Absolute change from baseline in inflammatory lesion counts in each treatment group at Week 12.
Time Frame
Week 12
Title
Change from baseline in non-inflammatory lesion counts
Description
Absolute change from baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Time Frame
Week 12
Title
Change from baseline in total lesion counts
Description
Absolute change from baseline in total lesions counts in each treatment group at Week 12.
Time Frame
Week 12
Title
Change from baseline in Investigator's Global Assessment (IGA)
Description
Absolute change from baseline in Investigator's Global Assessment (IGA) in each treatment group at Week 12.
Time Frame
Week 12
Title
Treatment success rate
Description
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.
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Local Adverse Reactions
Description
Local Adverse Reactions including erythema, scaling, stinging, burning and pruritus scored by severity
Time Frame
Week 2, Week 4, Week 8 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heng Gu, MD
Organizational Affiliation
Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210042
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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