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

Sun Pharmaceutical Industries, Inc.1,134 enrolled

Overview

Therapeutic equivalence and safety study

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,134

Conditions

Acne Vulgaris

Interventions

Test.DRUG

gel

Aczone Gel 5%DRUG

gel

PlaceboDRUG

gel

Eligibility

Sex: ALLMin age: 12 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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) Exclusion Criteria: * Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

Outcomes

Primary Outcomes

Change in inflammatory lesion count

Time frame: baseline to week 12 (study day 84)

Change in non-inflammatory lesion count

Time frame: baseline to week 12 (study day 84)

Data from ClinicalTrials.gov

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