NCT04321070

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Detailed description

Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Clindamycin Phosphate	A thin film of investigation product will be applied to the affected areas of the face once daily
DRUG	Clindamycin Phosphate RLD	A thin film of investigation product will be applied to the affected areas of the face once daily
DRUG	Placebos	A thin film of investigation product will be applied to the affected areas of the face once daily

Timeline

• Start date: 2019-09-09
• Primary completion: 2019-12-14
• Completion: 2020-03-06
• First posted: 2020-03-25
• Last updated: 2025-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study