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

NCT03615768 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1617

Last updated 2020-04-28

No results posted yet for this study

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

Interventions

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

DRUG

Clindamycin Gel

Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks

Sponsors & Collaborators

  • Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

    collaborator INDUSTRY

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Principal Investigators

  • Heng Gu, MD · Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-14
Primary Completion
2020-02-13
Completion
2020-04-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03615768 on ClinicalTrials.gov