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OpenTrials
Completed

NCT Number: NCT02935036

Efficacy Study in Patients With Acne Vulgaris.

Safety and efficacy study in patients with acne vulgaris

Completed

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ADPS topical product

Drug

topical product

Other names: Active

Placebo Control

Drug

topical product

Other names: vehicle

Primary outcomes

  1. Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face

    Time frame: Baseline to week 12 (study day 84)

  2. Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face

    Time frame: Baseline to week 12 (study day 84)

  3. The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.

    Time frame: Baseline to Week 12 (study day 84)

    Success was defined as an IGA score that was at least two grades less than the baseline assessment.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study to Evaluate the Efficacy and Safety of ADPS in the Treatment of Acne Vulgaris

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2016
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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