Study Comparing Test to Aczone 7.5% 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: DPSG 7.5%; Drug: Aczone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03132194

DPSG-1517

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,125 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,125 participants in 3 patient groups, including a placebo group

DPSG 7.5%

Experimental group

Description:

DPSG 7.5% (Taro Pharmaceuticals USA) Topical, twice daily on the face for 84 days.

Treatment:

Drug: DPSG 7.5%

Vehicle Gel

Placebo Comparator group

Description:

Placebo product (Taro Pharmaceuticals Inc.) Topical, twice daily on the face for 84 days.

Treatment:

Drug: Placebo

Aczone

Active Comparator group

Description:

dapsone 7.5 Topical, twice daily on the face for 84 days.

Treatment:

Drug: Aczone