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

• ClinicalTrials.gov Identifier: NCT03615768
• Recruitment Status: Completed
• First Posted: August 6, 2018
• Last Update Posted: April 28, 2020
• Sponsor: Lee's Pharmaceutical Limited
• Collaborator: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Information provided by (Responsible Party): Lee's Pharmaceutical Limited

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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Combination Product: Adapalene-Clindamycin Combination Gel; Drug: Adapalene Gel; Drug: Clindamycin Gel	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1617 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 14, 2018
• Actual Primary Completion Date: February 13, 2020
• Actual Study Completion Date: April 7, 2020

Arms and Interventions

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 Name: Differin
Active Comparator: Clindamycin Gel	Drug: Clindamycin Gel; Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks; Other Name: Clindamycin

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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 Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.

Other Outcome Measures:

1. 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

Eligibility Criteria

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

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

Contacts and Locations

Locations

China, Jiangsu

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

Nanjing, Jiangsu, China, 210042

Sponsors and Collaborators

Lee's Pharmaceutical Limited

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Investigators

• Principal Investigator: Heng Gu, MD; Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences

More Information

• Responsible Party: Lee's Pharmaceutical Limited
• ClinicalTrials.gov Identifier: NCT03615768
• Other Study ID Numbers: ZK-ACG-201712
• First Posted: August 6, 2018
• Last Update Posted: April 28, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents