Efficacy Study in Patients With Acne Vulgaris.

Taro Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Placebo Control; Drug: ADPS topical product

Study type: Interventional

Funder types: Industry

Identifiers

NCT02935036

ADPS 1602

Details and patient eligibility

About

Safety and efficacy study in patients with acne vulgaris

Full description

randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS in the treatment of acne vulgaris.

Enrollment: 294 patients

Sex: All

Ages: 9+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or non pregnant female aged ≥ 9 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

---

294 participants in 2 patient groups, including a placebo group

ADPS topical product

Experimental group

Description:

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

Treatment:

Drug: ADPS topical product

Placebo Control

Placebo Comparator group

Description:

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

Treatment:

Drug: Placebo Control