Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

Sun Pharmaceutical Industries, Inc.1,125 enrolled

Overview

To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,125

Conditions

Acne Vulgaris

Interventions

DPSG 7.5%DRUG

topical gel

AczoneDRUG

topical gel

PlaceboDRUG

topical gel

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris. Exclusion Criteria: * Female Subjects who are pregnant, nursing or planning to become pregnant during study participation

Outcomes

Primary Outcomes

Change in inflammatory lesion counts

Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

Time frame: 12 weeks

Change in non-inflammatory lesion counts

Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

Time frame: 12 weeks

Secondary Outcomes

Clinical response of success

The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment

Time frame: 12 weeks

Data from ClinicalTrials.gov

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