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Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel

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ClinicalTrials.gov Identifier: NCT01885910
Recruitment Status : Completed
First Posted : June 25, 2013
Results First Posted : February 26, 2015
Last Update Posted : February 27, 2015
Sponsor:
Collaborator:
WFH MEDICAL, LLC
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 Vulgaris
Interventions Drug: Doxycycline 100mg
Drug: Aczone 5% gel
Enrollment 32
Recruitment Details Recruitment at 2 sites for subjects at least 12 years of age with moderate to severe acne vulgaris began June 2013 and ended December 2013
Pre-assignment Details Any subject might be excluded who is not at least 12 years of age, who does not have moderate to severe acne vulgaris based upon IGA score and lesion counts, who has not completed the proper washout of specified medications, or who has been in another investigational study 30 days prior
Arm/Group Title Doxy + Aczone
Hide Arm/Group Description

Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily

Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks.

Period Title: Overall Study
Started 32
Completed 24
Not Completed 8
Arm/Group Title Aczone/Doxy
Hide Arm/Group Description subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
subjects at least 12 years of age who have moderate to severe acne vulgaris
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
24.8  (10.9)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
13
  40.6%
Between 18 and 65 years
19
  59.4%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
20
  62.5%
Male
12
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title Percentage of Participants Who Remained Responders at Week 24
Hide Description At week 12 responder had an IGA <3 on a 6-point scale ranging from 0 (clear) to 5 (very severe) and at Week 24 this response was maintained
Time Frame Assessed every 4 weeks, reported at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
only participants who were not lost to follow-up or did not withdraw consent were included in the final analysis
Arm/Group Title Aczone/Doxy
Hide Arm/Group Description:
subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of particpants
82
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aczone/Doxy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Inflammatory and Non-inflammatory Lesion Counts
Hide Description [Not Specified]
Time Frame Every 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with data
Arm/Group Title Aczone/Doxy - Inflammatory Aczone/Doxy - Non Inflammatory
Hide Arm/Group Description:
inflammatory lesion counts during treatment with aczone 5% and doxycycline 100mg
non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: lesions
baseline 27.3  (14.6) 38.3  (20.8)
week 16 (n=23,23) 5.8  (4.9) 10.0  (13.9)
week 20 (n=23,23) 7.3  (9.2) 8.3  (11.6)
week 24 (n=22,22) 7.0  (9.1) 6.6  (10.3)
3.Secondary Outcome
Title Percentage of Participants Who Are Responders at Week 16 and 20
Hide Description Responders is the percentage of participants who have an IGA <3 at Week 16 and 20
Time Frame Assessed every 4 weeks, reported at weeks 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aczone/Doxy
Hide Arm/Group Description:
subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: percentage of participants
responders at week 16 78
responders at week 20 87
4.Secondary Outcome
Title Nodule Counts
Hide Description number of nodules counted
Time Frame every four weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with data
Arm/Group Title Aczone/Doxy
Hide Arm/Group Description:
subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: nodules
Baseline 0.4  (0.7)
Week 16 (N=23) 0.1  (0.4)
Week 20 (N=23) 0.1  (0.5)
Week 24 (N=22) 0.3  (0.9)
5.Secondary Outcome
Title Erythema
Hide Description the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema
Time Frame every 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with data
Arm/Group Title Aczone/Doxy
Hide Arm/Group Description:
subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 1.3  (0.8)
week 16 (N=23) 0.7  (0.9)
week 20 (N=23) 0.9  (0.8)
week 24 (N=22) 1.1  (0.9)
6.Secondary Outcome
Title Dryness
Hide Description the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness
Time Frame every 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with data
Arm/Group Title Aczone/Doxy
Hide Arm/Group Description:
subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 0.6  (0.8)
week 16 (N=23) 0.3  (0.6)
week 20 (N=23) 0.1  (0.3)
week 24 (N=22) 0.1  (0.3)
7.Secondary Outcome
Title Peeling
Hide Description the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling
Time Frame every four weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with data
Arm/Group Title Aczone/Doxy
Hide Arm/Group Description:
subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 0.4  (0.9)
week 16 (N=23) 0.1  (0.3)
week 20 (N=23) 0.1  (0.3)
week 24 (N=22) 0.1  (0.3)
8.Secondary Outcome
Title Oiliness
Hide Description the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness
Time Frame every 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with data
Arm/Group Title Aczone/Doxy
Hide Arm/Group Description:
subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 1.6  (1.1)
week 16 (N=23) 0.8  (0.8)
week 20 (N=23) 0.6  (0.7)
week 24 (N=22) 0.3  (0.5)
9.Secondary Outcome
Title Pruritis
Hide Description the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis
Time Frame every 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with data
Arm/Group Title Aczone/Doxy
Hide Arm/Group Description:
subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 0.4  (0.8)
week 16 (N=23) 0.2  (0.6)
week 20 (N=23) 0.1  (0.3)
week 24 (N=22) 0  (0.2)
10.Secondary Outcome
Title Burning
Hide Description the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning
Time Frame every 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
participants with data
Arm/Group Title Aczone/Doxy
Hide Arm/Group Description:
subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 0.1  (0.5)
week 16 (N=23) 0.1  (0.4)
week 20 (N=23) 0  (0)
week 24 (N=22) 0  (0.2)
Time Frame 6 months
Adverse Event Reporting Description Subjects were interviewed regarding changes in their health and the severity of pruritis and burning at each study visit; each subject was graded at each study visit regarding their current severity of erythema, dryness, peeling and oiliness on a 5-point scale.
 
Arm/Group Title Doxy + Aczone
Hide Arm/Group Description

Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily

Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks.

All-Cause Mortality
Doxy + Aczone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Doxy + Aczone
Affected / at Risk (%) # Events
Total   0/32 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Doxy + Aczone
Affected / at Risk (%) # Events
Total   7/32 (21.88%)    
Gastrointestinal disorders   
nausea  [1]  3/32 (9.38%)  3
vomiting * [1]  1/32 (3.13%)  1
Skin and subcutaneous tissue disorders   
burning * [2]  1/32 (3.13%)  1
pruritis * [1]  1/32 (3.13%)  1
Vascular disorders   
headache * [1]  1/32 (3.13%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
resolved, no residual effects
[2]
not resolved, f/u deemed unnecessary
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Leon Kircik
Organization: DermResearch, PLLC
Phone: 502-451-9000
Responsible Party: Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT01885910     History of Changes
Other Study ID Numbers: IIT-000508
First Submitted: June 21, 2013
First Posted: June 25, 2013
Results First Submitted: October 7, 2014
Results First Posted: February 26, 2015
Last Update Posted: February 27, 2015