NCT01257906

Bioequivalence Study Comparing Clindamycin Phosphate (1.2%) and Tretinoin (0.025%) Topical Gel to Ziana and Placebo

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, VEHICLE-CONTROLLED, PARALLEL-GROUP STUDY COMPARING CLINDAMYCIN PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL (ACTAVIS MID-ATLANTIC LLC) TO ZIANA® (CLINDAMYCIN PHOSPHATE 1.2% AND TRETINOIN 0.025%) GEL (MEDICIS, THE DERMATOLOGY COMPANY®) AND BOTH ACTIVE TREATMENTS TO CLINDAMYCIN PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL PLACEBO (ACTAVIS MID-ATLANTIC LLC) IN THE TREATMENT OF MILD TO SEVERE ACNE VULGARIS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,225 (actual)
• Sponsor: Actavis Mid-Atlantic LLC · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) gel, marketed by Medicis, The Dermatology Company®, is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of clindamycin phosphate (1.2%) and tretinoin (0.025%) topical gel and the current study is designed to evaluate the bioequivalence of this formulation to ZIANA®.

Conditions

• MILD TO SEVERE ACNE VULGARIS

Interventions

Type	Name	Description
DRUG	CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL	Topical Gel applied in the evening for 84 days
DRUG	ZIANA®	Topical Gel applied in the evening for 84 days
DRUG	Vehicle Control	Topical Gel applied in the evening for 84 days.

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-12-10
• Last updated: 2010-12-10

Locations

1 site across 1 country: India