NCT03717506

Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,236 (actual)
• Sponsor: Balmoral Medical company · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	GDC 268 Lotion	GDC 268 is a topical lotion
DRUG	Clindamycin Phosphate Lotion 1%	Clindamycin Phosphate Lotion is an FDA-approved drug product
DRUG	GDC Vehicle Lotion	GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs

Timeline

• Start date: 2018-10-10
• Primary completion: 2020-02-17
• Completion: 2020-04-16
• First posted: 2018-10-24
• Last updated: 2021-05-04
• Results posted: 2021-05-04

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated drug study