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Trial record 63 of 134 for:    acne AND peroxide

A Novel Method to Improve Acne Outcomes

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ClinicalTrials.gov Identifier: NCT01176955
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : October 21, 2011
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Behavioral: Internet survey
Drug: Benzoyl peroxide 5% gel
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Internet Survey Control
Hide Arm/Group Description Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication. Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
Period Title: Overall Study
Started 10 10
Completed 7 8
Not Completed 3 2
Arm/Group Title Internet Survey Control Total
Hide Arm/Group Description Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication. Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
10
 100.0%
10
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
15.3  (1.49) 15.5  (2.22) 15.4  (1.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
8
  80.0%
4
  40.0%
12
  60.0%
Male
2
  20.0%
6
  60.0%
8
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.
Hide Description Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported. Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps. Adherence was monitored objectively with electronic monitors that recorded the date and time when the medication containers were opened (medication event monitoring system caps). Adherence was rated as a percentage of days the medication container was opened; adherence could be greater than 100% if the container was opened more than once per day.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Internet Survey Control
Hide Arm/Group Description:
Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
Overall Number of Participants Analyzed 7 8
Median (Full Range)
Unit of Measure: percentage of days containers were open
74
(58 to 132)
32
(4 to 80)
2.Secondary Outcome
Title The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.
Hide Description Acne Global Assessment is measured by a study investigator and is an overall assessment of the subject's acne severity, on a 0 (clear) to 5 (very severe) scale.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Internet Survey Control
Hide Arm/Group Description:
Patients received a weekly Internet survey to report on the status of their acne.
Patients received standard-of-care therapy without weekly Internet surveys.
Overall Number of Participants Analyzed 7 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.71  (0.76) -0.25  (0.46)
3.Secondary Outcome
Title The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.
Hide Description Both inflammatory (papules, pustules and nodules) and non-inflammatory (open and closed comedones) acne lesions will be counted by a study investigator. Percentage change from baseline to the final study visit will be calculated.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Internet Survey Control
Hide Arm/Group Description:
Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
Overall Number of Participants Analyzed 7 8
Mean (Standard Deviation)
Unit of Measure: percent change in lesion count
-36  (37) -8  (65)
4.Secondary Outcome
Title The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.
Hide Description All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
This group includes all participants in the study.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Spearman's Rank Correlation Coefficient
0.53
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Internet Survey Control
Hide Arm/Group Description Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication. Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
All-Cause Mortality
Internet Survey Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Internet Survey Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Internet Survey Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
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: Brad Yentzer
Organization: Wake Forest Baptist Medical Center
Phone: 336-716-4735
EMail: byentzer@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT01176955     History of Changes
Other Study ID Numbers: IRB00008982
First Submitted: August 5, 2010
First Posted: August 6, 2010
Results First Submitted: July 1, 2011
Results First Posted: October 21, 2011
Last Update Posted: August 16, 2018