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Trial record 15 of 134 for:    acne AND peroxide

Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne

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ClinicalTrials.gov Identifier: NCT00658112
Recruitment Status : Completed
First Posted : April 14, 2008
Results First Posted : March 17, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Intervention Drug: Benzoyl Peroxide
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Benzoyl Peroxide 5%
Hide Arm/Group Description

Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.

Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.

Period Title: Overall Study
Started 20
Completed 11
Not Completed 9
Arm/Group Title Benzoyl Peroxide 5%
Hide Arm/Group Description

Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.

Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
11
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
8
  72.7%
Male
3
  27.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   9.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  63.6%
White
3
  27.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
 100.0%
1.Primary Outcome
Title Adherence
Hide Description Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Benzoyl Peroxide 5%
Hide Arm/Group Description:

Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.

Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.

Overall Number of Participants Analyzed 11
Mean (Full Range)
Unit of Measure: percentage of doses actually applied
46.5
(14 to 79)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benzoyl Peroxide 5%
Hide Arm/Group Description

Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.

Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.

All-Cause Mortality
Benzoyl Peroxide 5%
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Benzoyl Peroxide 5%
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Benzoyl Peroxide 5%
Affected / at Risk (%)
Total   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steve Feldman MD
Organization: Wake Forest University Health Sciences
Phone: 336-716-3775
EMail: sfeldman@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT00658112     History of Changes
Other Study ID Numbers: IRB0000027
First Submitted: April 9, 2008
First Posted: April 14, 2008
Results First Submitted: January 27, 2017
Results First Posted: March 17, 2017
Last Update Posted: August 28, 2018