Efficacy Study in Patients With Acne Vulgaris.

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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

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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