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

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ClinicalTrials.gov Identifier: NCT03132194
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: DPSG 7.5% Drug: Aczone Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris
Actual Study Start Date : August 8, 2016
Actual Primary Completion Date : January 16, 2017
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Dapsone

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 Name: dapsone

Placebo Comparator: Vehicle Gel

Placebo product (Taro Pharmaceuticals Inc.)

Topical, twice daily on the face for 84 days.

Drug: Placebo
topical gel
Other Name: Vehicle

Active Comparator: Aczone

dapsone 7.5

Topical, twice daily on the face for 84 days.

Drug: Aczone
topical gel
Other Name: dapsone




Primary Outcome Measures :
  1. Change in inflammatory lesion counts [ Time Frame: 12 weeks ]
    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

  2. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132194


Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Catawba Research http://catawbaresearch.com/contact/

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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT03132194     History of Changes
Other Study ID Numbers: DPSG-1517
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Dapsone
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents