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

Primary Purpose

Acne

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dapsone 7.5 % gel
Sponsored by
Derm Research, PLLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dermatology and Laser Surgery
  • DermResearch, PLLC
  • James Q. DelRosso DO, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dapsone gel 7.5%

Arm Description

Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.

Outcomes

Primary Outcome Measures

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
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

The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline
The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline
The Percent Change in Total Lesion Count at Week 16 Compared to Baseline

Full Information

First Posted
October 4, 2016
Last Updated
March 20, 2019
Sponsor
Derm Research, PLLC
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1. Study Identification

Unique Protocol Identification Number
NCT02944461
Brief Title
Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
Official Title
Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Derm Research, PLLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dapsone gel 7.5%
Arm Type
Experimental
Arm Description
Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Dapsone 7.5 % gel
Other Intervention Name(s)
Aczone
Intervention Description
Dapsone gel 7.5% applied once daily to truncal acne
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline
Time Frame
16 Weeks
Title
The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline
Time Frame
16 Weeks
Title
The Percent Change in Total Lesion Count at Week 16 Compared to Baseline
Time Frame
16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon H. Kircik, M.D.
Organizational Affiliation
DermResearch PLLC
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology and Laser Surgery
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
DermResearch, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40014
Country
United States
Facility Name
James Q. DelRosso DO, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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