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Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02944461
Recruitment Status : Completed
First Posted : October 25, 2016
Results First Posted : March 1, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Derm Research, PLLC

Study Description
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Brief Summary:
To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk

Condition or disease Intervention/treatment Phase
Acne Drug: Dapsone 7.5 % gel Phase 4

Detailed Description:
This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
Study Start Date : October 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Dapsone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dapsone gel 7.5%
Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.
 Drug: Dapsone 7.5 % gel
Dapsone gel 7.5% applied once daily to truncal acne
Other Name: Aczone


Outcome Measures
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Primary Outcome Measures :
  1. Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale [ Time Frame: 16 weeks ]
    Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe


Secondary Outcome Measures :
  1. The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline [ Time Frame: 16 Weeks ]
  2. The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline [ Time Frame: 16 Weeks ]
  3. The Percent Change in Total Lesion Count at Week 16 Compared to Baseline [ Time Frame: 16 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects of any race and at least 12 years of age.
  • Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
  • Truncal acne IGA score of 3.
  • Able to understand the requirements of study and sign Informed Consent/HIPAA forms.

Exclusion Criteria:

  • Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control.
  • Subjects who have an allergy or sensitivity to any component of the test medication.
  • Subjects who have not complied with the proper wash out periods for prohibited medications.
  • Evidence of recent drug or alcohol abuse.
  • Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne.
  • Exposure to an investigational drug within 30 days of the Baseline visit.
  • Medical condition that contraindicates the subject's participation in the study.
  • History of poor cooperation, non-compliance with medical treatment or unreliability.
Contacts and Locations
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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): NCT02944461


Locations
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United States, California
Dermatology and Laser Surgery
Sacramento, California, United States, 95819
United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40014
United States, Nevada
James Q. DelRosso DO, LLC
Las Vegas, Nevada, United States, 89117
Sponsors and Collaborators
Derm Research, PLLC
Investigators
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Study Director: Leon H. Kircik, M.D. DermResearch PLLC
  Study Documents (Full-Text)

Documents provided by Derm Research, PLLC:
Study Protocol and Statistical Analysis Plan  [PDF] June 1, 2016

More Information
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Responsible Party: Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT02944461    
Other Study ID Numbers: ACZ1601
First Posted: October 25, 2016    Key Record Dates
Results First Posted: March 1, 2019
Last Update Posted: April 3, 2019
Last Verified: March 2019
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