Trial Outcomes & Findings for Patient Education in Adherence on Acne (PEAce) (NCT NCT02307266)
NCT ID: NCT02307266
Last Updated: 2021-02-18
Results Overview
To prevent bias, treatment adherence was assessed without subject's knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100. Analysis was performed on the "worst-case" population: Missing data were considered as non-adherence.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
97 participants
Primary outcome timeframe
week 12
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
Standard of Care + Supplementary Education
Subjects received supplementary patient educational material in addition to standard-of-care instructions.
|
Standard of Care
Subjects received standard-of-care instructions only.
|
Standard of Care + Additional Visits
Subjects received standard-of-care instructions, and two additional clinical visits.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
31
|
|
Overall Study
COMPLETED
|
25
|
32
|
25
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
6
|
Reasons for withdrawal
| Measure |
Standard of Care + Supplementary Education
Subjects received supplementary patient educational material in addition to standard-of-care instructions.
|
Standard of Care
Subjects received standard-of-care instructions only.
|
Standard of Care + Additional Visits
Subjects received standard-of-care instructions, and two additional clinical visits.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
0
|
Baseline Characteristics
Patient Education in Adherence on Acne (PEAce)
Baseline characteristics by cohort
| Measure |
Standard of Care + Supplementary Education
n=33 Participants
Subjects received supplementary patient educational material in addition to standard-of-care instructions.
|
Standard of Care
n=33 Participants
Subjects received standard-of-care instructions only.
|
Standard of Care + Additional Visits
n=31 Participants
Subjects received standard-of-care instructions, and two additional clinical visits.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
24.1 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
21.0 years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
22.5 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
22.5 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
82 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Skin Phototype
I
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Skin Phototype
II
|
11 participants
n=99 Participants
|
9 participants
n=107 Participants
|
11 participants
n=206 Participants
|
31 participants
n=7 Participants
|
|
Skin Phototype
III
|
14 participants
n=99 Participants
|
13 participants
n=107 Participants
|
12 participants
n=206 Participants
|
39 participants
n=7 Participants
|
|
Skin Phototype
IV
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
4 participants
n=206 Participants
|
15 participants
n=7 Participants
|
|
Skin Phototype
V
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Investigator Global Assessment of Acne
Almost clear
|
8 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
12 participants
n=7 Participants
|
|
Investigator Global Assessment of Acne
Mild
|
17 participants
n=99 Participants
|
22 participants
n=107 Participants
|
20 participants
n=206 Participants
|
59 participants
n=7 Participants
|
|
Investigator Global Assessment of Acne
Moderate
|
8 participants
n=99 Participants
|
10 participants
n=107 Participants
|
8 participants
n=206 Participants
|
26 participants
n=7 Participants
|
|
Acne History
Less than 1 year
|
12 participants
n=99 Participants
|
9 participants
n=107 Participants
|
7 participants
n=206 Participants
|
28 participants
n=7 Participants
|
|
Acne History
Between 1 and 5 years
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
17 participants
n=206 Participants
|
40 participants
n=7 Participants
|
|
Acne History
More than 5 years
|
10 participants
n=99 Participants
|
12 participants
n=107 Participants
|
7 participants
n=206 Participants
|
29 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: week 12Population: Only subjects with usable MEMS data were analyzed, therefore the number of subjects in the analysis population is not the full population.
To prevent bias, treatment adherence was assessed without subject's knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100. Analysis was performed on the "worst-case" population: Missing data were considered as non-adherence.
Outcome measures
| Measure |
Standard of Care + Supplementary Education
n=20 Participants
Subjects received supplementary patient educational material in addition to standard-of-care instructions.
|
Standard of Care
n=28 Participants
Subjects received standard-of-care instructions only.
|
Standard of Care + Additional Visits
n=23 Participants
Subjects received standard-of-care instructions, and two additional clinical visits.
|
|---|---|---|---|
|
Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)
|
63.1 percentage of adherence
Standard Deviation 30.2
|
56.5 percentage of adherence
Standard Deviation 24.8
|
48.2 percentage of adherence
Standard Deviation 33.9
|
Adverse Events
Standard of Care + Supplementary Education
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Standard of Care + Additional Visits
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care + Supplementary Education
n=33 participants at risk
Subjects received supplementary patient educational material in addition to standard-of-care instructions.
|
Standard of Care
n=33 participants at risk
Subjects received standard-of-care instructions only.
|
Standard of Care + Additional Visits
n=31 participants at risk
Subjects received standard-of-care instructions, and two additional clinical visits.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
9.7%
3/31 • Number of events 3 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/33 • 12 weeks
|
6.1%
2/33 • Number of events 2 • 12 weeks
|
6.5%
2/31 • Number of events 2 • 12 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.1%
2/33 • Number of events 2 • 12 weeks
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
3.2%
1/31 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
0.00%
0/33 • 12 weeks
|
6.5%
2/31 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
3.2%
1/31 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
6.1%
2/33 • Number of events 2 • 12 weeks
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
0.00%
0/31 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/33 • 12 weeks
|
0.00%
0/33 • 12 weeks
|
6.5%
2/31 • Number of events 3 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/33 • 12 weeks
|
0.00%
0/33 • 12 weeks
|
6.5%
2/31 • Number of events 2 • 12 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/33 • 12 weeks
|
0.00%
0/33 • 12 weeks
|
6.5%
2/31 • Number of events 2 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure agreement covered by contract.
- Publication restrictions are in place
Restriction type: OTHER