Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Test.; Drug: Aczone Gel 5%; Drug: Placebo

• Registration Number: NCT02929719
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

Therapeutic equivalence and safety study

Detailed Description

To evaluate the therapeutic equivalence and safety of Test formulation and marketed Reference Listed Drug (RLD).

To demonstrate the superiority of efficacy of the Test and Reference products over the placebo control in the treatment.

To compare the safety of Test, Reference and Placebo treatments.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-10-08
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1134

Inclusion Criteria

• Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris
• Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below)

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Exclusion Criteria

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Gel 5%	Test.	Topical, twice daily on the face for 84 days.
ACZONE Gel 5%	Aczone Gel 5%	Topical, twice daily on the face for 84 days
Placebo Gel	Placebo	Topical, twice daily on the face for 84 days

Primary Outcome Measures

Name	Time	Method
Change in inflammatory lesion count	baseline to week 12 (study day 84)
Change in non-inflammatory lesion count	baseline to week 12 (study day 84)