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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-06-30

Brief Summary

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Therapeutic equivalence and safety study

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Detailed Description

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test Gel 5%

Topical, twice daily on the face for 84 days.

Group Type EXPERIMENTAL

Test.

Intervention Type DRUG

gel

ACZONE Gel 5%

Topical, twice daily on the face for 84 days

Group Type ACTIVE_COMPARATOR

Aczone Gel 5%

Intervention Type DRUG

gel

Placebo Gel

Topical, twice daily on the face for 84 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

gel

Interventions

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Test.

gel

Intervention Type DRUG

Aczone Gel 5%

gel

Intervention Type DRUG

Placebo

gel

Intervention Type DRUG

Other Intervention Names

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dapsone Vehicle dapsone

Eligibility Criteria

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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)