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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne
Intervention Drug: Dapsone 7.5 % gel
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dapsone Gel 7.5%
Hide Arm/Group Description

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

Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne

Period Title: Overall Study
Started 20
Completed 15
Not Completed 5
Arm/Group Title Dapsone Gel 7.5%
Hide Arm/Group Description

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

Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
21  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
11
  55.0%
Male
9
  45.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
2
  10.0%
Not Hispanic or Latino
2
  10.0%
Unknown or Not Reported
16
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapsone Gel 7.5%
Hide Arm/Group Description:

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

Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
week 4
0
   0.0%
week 10
3
  20.0%
week 16
7
  46.7%
2.Secondary Outcome
Title The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline
Hide Description [Not Specified]
Time Frame 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapsone Gel 7.5%
Hide Arm/Group Description:

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

Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: percent change in lesion count
-74  (21)
3.Secondary Outcome
Title The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline
Hide Description [Not Specified]
Time Frame 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapsone Gel 7.5%
Hide Arm/Group Description:

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

Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: percent change in lesion count
-72  (28)
4.Secondary Outcome
Title The Percent Change in Total Lesion Count at Week 16 Compared to Baseline
Hide Description [Not Specified]
Time Frame 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapsone Gel 7.5%
Hide Arm/Group Description:

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

Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: percent change in lesion count
-73  (23)
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dapsone Gel 7.5%
Hide Arm/Group Description

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

Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne

All-Cause Mortality
Dapsone Gel 7.5%
Affected / at Risk (%)
Total   0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dapsone Gel 7.5%
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dapsone Gel 7.5%
Affected / at Risk (%) # Events
Total   3/20 (15.00%)    
Eye disorders   
stye, right eye   1/20 (5.00%)  1
Skin and subcutaneous tissue disorders   
infected abrasions of legs   1/20 (5.00%)  1
sunburn arms/chest/back   1/20 (5.00%)  1
Surgical and medical procedures   
gum graft surgery   1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: M. McAllister
Organization: Skin Sciences, PLLC
Phone: 5024519000
EMail: mmdermresearch@yahoo.com
Layout table for additonal information
Responsible Party: Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT02944461     History of Changes
Other Study ID Numbers: ACZ1601
First Submitted: October 4, 2016
First Posted: October 25, 2016
Results First Submitted: February 7, 2019
Results First Posted: March 1, 2019
Last Update Posted: April 3, 2019