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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Placebo; Drug: Aczone Gel 5%; Drug: Test.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02929719

DPSG 1518, 1216

Details and patient eligibility

About

Therapeutic equivalence and safety study

Full 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.

Enrollment: 1,134 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,134 participants in 3 patient groups, including a placebo group

Test Gel 5%

Experimental group

Description:

Topical, twice daily on the face for 84 days.

Treatment:

Drug: Test.

ACZONE Gel 5%

Active Comparator group

Description:

Topical, twice daily on the face for 84 days

Treatment:

Drug: Aczone Gel 5%

Placebo Gel

Placebo Comparator group

Description:

Topical, twice daily on the face for 84 days

Treatment:

Drug: Placebo