Trial Outcomes & Findings for Effect of Samples on Acne Treatment With Epiduo® Gel (NCT NCT01504204)
NCT ID: NCT01504204
Last Updated: 2018-09-12
Results Overview
Adherence will be reported as percentage of prescribed doses taken as measured electronically by a Medication Event Monitoring System (MEMS®) cap.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline to 6 weeks
Results posted on
2018-09-12
Participant Flow
Subjects were recruited from Wake Forest Baptist Medical Center Dermatology clinic and phone database of previously seen mild to moderate acne.
Participant milestones
| Measure |
Medication With Sample and Demonstration
Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.
|
Medication Without Samples
Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Medication With Sample and Demonstration
Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.
|
Medication Without Samples
Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Effect of Samples on Acne Treatment With Epiduo® Gel
Baseline characteristics by cohort
| Measure |
Medication With Sample and Demonstration
n=9 Participants
Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.
Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.
Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
|
Medication Without Samples
n=9 Participants
Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
19 years
n=5 Participants
|
19 years
n=7 Participants
|
19 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race(Caucasian)
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity(Non-Hispanic)
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksPopulation: the median and ranges of subject ages for the sample and no sample group were 19 years, primarily female identifying as Caucasian.
Adherence will be reported as percentage of prescribed doses taken as measured electronically by a Medication Event Monitoring System (MEMS®) cap.
Outcome measures
| Measure |
Medication With Sample and Demonstration
n=9 Participants
Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.
Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.
Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
|
Medication Without Samples
n=9 Participants
Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
|
|---|---|---|
|
Adherence to Study Medication
|
86 percentage of doses
Standard Deviation 2.2
|
71 percentage of doses
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksChange in the physician's global assessment of acne severity on a validated 0-5 scale (0=clear to 5=very severe) from baseline to Week 6 visit.
Outcome measures
| Measure |
Medication With Sample and Demonstration
n=9 Participants
Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.
Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.
Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
|
Medication Without Samples
n=9 Participants
Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
|
|---|---|---|
|
Change in Acne Global Assessment
Baseline · AGA (2-mild)
|
5 Participants
|
6 Participants
|
|
Change in Acne Global Assessment
Baseline · AGA (3 moderate)
|
4 Participants
|
3 Participants
|
|
Change in Acne Global Assessment
Baseline · AGA (1 almost clear)
|
0 Participants
|
0 Participants
|
|
Change in Acne Global Assessment
Week 6 · AGA (2-mild)
|
3 Participants
|
4 Participants
|
|
Change in Acne Global Assessment
Week 6 · AGA (3 moderate)
|
2 Participants
|
3 Participants
|
|
Change in Acne Global Assessment
Week 6 · AGA (1 almost clear)
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksChange in total count of acne lesions from baseline visit to Week 6 visit
Outcome measures
| Measure |
Medication With Sample and Demonstration
n=9 Participants
Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.
Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.
Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
|
Medication Without Samples
n=9 Participants
Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
|
|---|---|---|
|
Change in Acne Lesion Count
Basleine (Inflammatory Lesions)
|
3 lesions
Interval 0.0 to 10.0
|
2 lesions
Interval 0.0 to 12.0
|
|
Change in Acne Lesion Count
Baseline (Non-Inflammatory)
|
33 lesions
Interval 16.0 to 57.0
|
38 lesions
Interval 6.0 to 62.0
|
|
Change in Acne Lesion Count
Week 6 (inflammatory Lesion)
|
1 lesions
Interval 0.0 to 9.0
|
1 lesions
Interval 0.0 to 14.0
|
|
Change in Acne Lesion Count
Week 6 (Non-inflammatory Lesion)
|
19 lesions
Interval 5.0 to 40.0
|
35 lesions
Interval 4.0 to 53.0
|
Adverse Events
Medication With Sample and Demonstration
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Medication Without Samples
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Medication With Sample and Demonstration
n=10 participants at risk
Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.
Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.
Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
|
Medication Without Samples
n=10 participants at risk
Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dryness
|
30.0%
3/10 • Number of events 3 • One year
Eighteen subjects completed questionnaires regarding side effects.
|
30.0%
3/10 • Number of events 3 • One year
Eighteen subjects completed questionnaires regarding side effects.
|
|
Skin and subcutaneous tissue disorders
itching
|
30.0%
3/10 • Number of events 3 • One year
Eighteen subjects completed questionnaires regarding side effects.
|
20.0%
2/10 • Number of events 2 • One year
Eighteen subjects completed questionnaires regarding side effects.
|
|
Skin and subcutaneous tissue disorders
redness
|
0.00%
0/10 • One year
Eighteen subjects completed questionnaires regarding side effects.
|
10.0%
1/10 • Number of events 1 • One year
Eighteen subjects completed questionnaires regarding side effects.
|
Additional Information
Irma M Richardsom, MHA
Wake Forest University Health Sciences
Phone: 336-716-2903
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place