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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Combination product: Adapalene-Clindamycin Combination Gel; Drug: Adapalene Gel; Drug: Clindamycin Gel

• Study Type: Interventional
• Enrollment (Actual): 1617
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adapalene-Clindamycin Combination Gel	Combination product: Adapalene-Clindamycin Combination Gel; 5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks
Active Comparator: Adapalene Gel	Drug: Adapalene Gel; Differin 0.1% Gel, applied nightly for 12 weeks; Other Names: Differin
Active Comparator: Clindamycin Gel	Drug: Clindamycin Gel; Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks; Other Names: Clindamycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Baseline in Total Lesion Counts	Percent change from Baseline in total lesions counts in each treatment group at Week 12.	Week 12
Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline		Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change from baseline in inflammatory lesion counts	Percent change from baseline in inflammatory lesions count in each treatment group at Week 12.	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.	Week 12
Change from baseline in inflammatory lesion counts	Absolute change from baseline in inflammatory lesion counts in each treatment group at Week 12.	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.	Week 12
Change from baseline in total lesion counts	Absolute change from baseline in total lesions counts in each treatment group at Week 12.	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.	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.	Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Adverse Reactions	Local Adverse Reactions including erythema, scaling, stinging, burning and pruritus scored by severity	Week 2, Week 4, Week 8 and Week 12

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited
• Collaborators: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Investigators: Principal Investigator: Heng Gu, MD, Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2018
• Primary Completion (Actual): February 13, 2020
• Study Completion (Actual): April 7, 2020

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene
• Other Study ID Numbers: ZK-ACG-201712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No