Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

May 3, 2017 updated by: Taro Pharmaceuticals USA

A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1125

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DPSG 7.5%

DPSG 7.5% (Taro Pharmaceuticals USA)

Topical, twice daily on the face for 84 days.
Drug: DPSG 7.5%
topical gel
Other Names:
  • dapsone
PLACEBO_COMPARATOR: Vehicle Gel

Placebo product (Taro Pharmaceuticals Inc.)

Topical, twice daily on the face for 84 days.
Drug: Placebo
topical gel
Other Names:
  • Vehicle
ACTIVE_COMPARATOR: Aczone

dapsone 7.5

Topical, twice daily on the face for 84 days.
Drug: Aczone
topical gel
Other Names:
  • dapsone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inflammatory lesion counts
Time Frame: 12 weeks
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
12 weeks
Change in non-inflammatory lesion counts
Time Frame: 12 weeks
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response of success
Time Frame: 12 weeks
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taro Pharmaceuticals USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 8, 2016

Primary Completion (ACTUAL)

January 16, 2017

Study Completion (ACTUAL)

January 30, 2017

Study Registration Dates

First Submitted

March 16, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (ACTUAL)

April 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPSG-1517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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