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

NCT03615768 | Completed Phase 3

• 1 other identifier: ZK-ACG-201712
• Study Type: interventional
• Target: 1,617
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Percentage change from baseline in inflammatory lesion counts

  Week 12

• Percentage change from baseline in non-inflammatory lesion counts

  Week 12

• Change from baseline in inflammatory lesion counts

  Week 12

• Change from baseline in non-inflammatory lesion counts

  Week 12

• Change from baseline in total lesion counts

  Week 12

Other Outcomes (1)

• Local Adverse Reactions

  Week 2, Week 4, Week 8 and Week 12

Study Arms (3)

Adapalene-Clindamycin Combination Gel

EXPERIMENTAL

Combination Product: Adapalene-Clindamycin Combination Gel

Adapalene Gel

ACTIVE COMPARATOR

Drug: Adapalene Gel

Clindamycin Gel

ACTIVE COMPARATOR

Drug: Clindamycin Gel

Interventions

Adapalene-Clindamycin Combination Gel COMBINATION_PRODUCT

5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks

Adapalene-Clindamycin Combination Gel

Adapalene Gel DRUG

Differin 0.1% Gel, applied nightly for 12 weeks

Also known as: Differin

Adapalene Gel

Clindamycin Gel DRUG

Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks

Also known as: Clindamycin

Clindamycin Gel

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead
• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: collaborator

Study Sites (1)

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

Nanjing, Jiangsu, 210042, China

Location

Related Publications (1)

• Luan C, Yang WL, Yin JW, Deng LH, Chen B, Liu HW, Zhang SM, Han J, Liu ZJ, Dai XR, Yin QJ, Yu XH, Chen K, Gu H, Li BXY. Efficacy and Safety of a Fixed-Dose Combination Gel with Adapalene 0.1% and Clindamycin 1% for the Treatment of Acne Vulgaris (CACTUS): A Randomized, Controlled, Assessor-Blind, Phase III Clinical Trial. Dermatol Ther (Heidelb). 2024 Nov;14(11):3097-3112. doi: 10.1007/s13555-024-01286-x. Epub 2024 Nov 1.

  PMID: 39487326 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Clindamycin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Heng Gu, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: August 14, 2018
• Primary Completion: February 13, 2020
• Study Completion: April 7, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)