Efficacy Study in Patients With Acne Vulgaris.

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: ADPS topical product; Drug: Placebo Control

• Registration Number: NCT02935036
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

Safety and efficacy study in patients with acne vulgaris

Detailed Description

randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS in the treatment of acne vulgaris.

Study Timeline

• Study Start: 2016-10-03
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Primary Completion: 2017-01-24
• Study Completion: 2017-03-21
• Results First Submitted: 2018-08-21
• Results First Submitted QC: 2018-08-21
• Status Verified: 2018-09
• Results First Posted: 2018-09-18
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

• Healthy male or non pregnant female aged ≥ 9 years with a clinical diagnosis of acne vulgaris

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADPS topical product	ADPS topical product	A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
Placebo Control	Placebo Control	A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face	Baseline to week 12 (study day 84)
Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face	Baseline to week 12 (study day 84)
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.	Baseline to Week 12 (study day 84)	Success was defined as an IGA score that was at least two grades less than the baseline assessment.