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OpenTrials
Completed

NCT Number: NCT02929719

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

Therapeutic equivalence and safety study

Completed

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Key information

Conditions

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

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

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 ≥ 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.

Treatment and study plan

Test.

Drug

gel

Other names: dapsone

Aczone Gel 5%

Drug

gel

Other names: dapsone

Placebo

Drug

gel

Other names: Vehicle

Primary outcomes

  1. Change in inflammatory lesion count

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

  2. Change in non-inflammatory lesion count

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

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, Comparing Test Gel, 5% to ACZONE Gel, 5% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 11, 2016
Registry last updated
May 4, 2017

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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