NCT03615768

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,617 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-08-14
• Primary completion: 2020-02-13
• Completion: 2020-04-07
• First posted: 2018-08-06
• Last updated: 2020-04-28

Locations

1 site across 1 country: China