Trial Outcomes & Findings for Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit (NCT NCT00654355)

Results Overview

adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Week 4

Results posted on

2018-08-01

Participant Flow

Subjects were recruited from the Dermatology Studies Center and IRB approved advertising.

Participant milestones

Participant milestones
Measure	Control Group Group only had visits at Baseline and Week 4.	Extra Visit Group After Baseline, this group had an extra visit at week 1.
Overall Study STARTED	15	15
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Group only had visits at Baseline and Week 4.	Extra Visit Group After Baseline, this group had an extra visit at week 1.
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=15 Participants Group only had visits at Baseline and Week 4.	Extra Visit Group n=15 Participants After Baseline, this group had an extra visit at week 1.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 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
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed

Outcome measures

Outcome measures
Measure	Control Group n=15 Participants Group only had visits at Baseline and Week 4.	Extra Visit Group n=15 Participants After Baseline, this group had an extra visit at week 1.
Adherence	56 percentage of required applicaitons Interval 15.0 to 79.0	72 percentage of required applicaitons Interval 39.0 to 114.0

SECONDARY outcome

Timeframe: Week 4

Investigator Global Assessment: Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from '0' = clear or "No inflammatory signs of AD" to '4' = Very Severe Disease with "severe erythema and severe papulation/infiltration with oozing/crusting."

Outcome measures

Outcome measures
Measure	Control Group n=15 Participants Group only had visits at Baseline and Week 4.	Extra Visit Group n=15 Participants After Baseline, this group had an extra visit at week 1.
The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.	-33 % change in IGA Interval -44.0 to -18.0	-33 % change in IGA Interval -54.0 to -30.0

SECONDARY outcome

Timeframe: Week 4

Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.

Outcome measures

Outcome measures
Measure	Control Group n=15 Participants Group only had visits at Baseline and Week 4.	Extra Visit Group n=15 Participants After Baseline, this group had an extra visit at week 1.
EASI	2.1 units on a scale Standard Deviation 5.7	1 units on a scale Standard Deviation 2.6

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Extra Visit Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control Group n=15 participants at risk Group only had visits at Baseline and Week 4.	Extra Visit Group n=15 participants at risk After Baseline, this group had an extra visit at week 1.
Respiratory, thoracic and mediastinal disorders Upper respiratory Infection	20.0% 3/15 • Number of events 3	13.3% 2/15 • Number of events 2

Additional Information

Steven Feldman, MD, PhD

Wake Forest University Health Sciences

Phone: 336-716-3885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place