Trial Outcomes & Findings for A Novel Method to Improve Acne Outcomes (NCT NCT01176955)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Internet Survey Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.	Control 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 Study STARTED	10	10
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Novel Method to Improve Acne Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Internet Survey n=10 Participants Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.	Control n=10 Participants 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 n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	15.3 years STANDARD_DEVIATION 1.49 • n=5 Participants	15.5 years STANDARD_DEVIATION 2.22 • n=7 Participants	15.4 years STANDARD_DEVIATION 1.85 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Internet Survey n=7 Participants Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.	Control n=8 Participants 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.
The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.	74 percentage of days containers were open Interval 58.0 to 132.0	32 percentage of days containers were open Interval 4.0 to 80.0

SECONDARY outcome

Timeframe: Baseline to 12 weeks

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.

Outcome measures

Outcome measures
Measure	Internet Survey n=7 Participants Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.	Control n=8 Participants 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.
The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.	-0.71 units on a scale Standard Deviation 0.76	-0.25 units on a scale Standard Deviation 0.46

SECONDARY outcome

Timeframe: Baseline to 12 weeks

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.

Outcome measures

Outcome measures
Measure	Internet Survey n=7 Participants Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.	Control n=8 Participants 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.
The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.	-36 percent change in lesion count Standard Deviation 37	-8 percent change in lesion count Standard Deviation 65

SECONDARY outcome

Timeframe: 12 weeks

All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.

Outcome measures

Outcome measures
Measure	Internet Survey n=18 Participants Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.	Control 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.
The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.	0.53 Spearman's Rank Correlation Coefficient	—

Adverse Events

Internet Survey

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brad Yentzer

Wake Forest Baptist Medical Center

Phone: 336-716-4735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place