Trial Outcomes & Findings for Internet Surveys and Their Impact on Adherence for Rosacea (NCT NCT03048058)

Last Updated: 2018-10-10

Results Overview

To assess adherence to topical brimonidine for the treatment of rosacea as measured by MEMS caps. The result will be the % of prescribed doses that were actually taken by the subject

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

6 months

Results posted on

2018-10-10

Participant Flow

20 subjects male/female aged 18 years and older with the diagnosis of persistent erythema associated with mild to moderate rosacea as defined by an Investigator Global Assessment rating between 2 and 5. Patients were recruited from Wake Forest University Department of Dermatology Clinics and via Institutional Review Board approved advertising.

Participant milestones

Participant milestones
Measure	Brimonidine Topical Gel 0.33% & Survey The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication. brimonidine topical gel 0.33% \& survey: The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication,	Brimonidine Topical Gel 0.33% & SOC Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits brimonidine topical gel 0.33% \& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%
Overall Study STARTED	10	10
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Brimonidine Topical Gel 0.33% & Survey The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication. brimonidine topical gel 0.33% \& survey: The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication,	Brimonidine Topical Gel 0.33% & SOC Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits brimonidine topical gel 0.33% \& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%
Overall Study Lost to Follow-up	4	0
Overall Study Withdrawal by Subject	0	4

Baseline Characteristics

Gender not collected for all participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brimonidine Topical Gel 0.33% & Survey n=10 Participants The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication. brimonidine topical gel 0.33% \& survey: The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication,	Brimonidine Topical Gel 0.33% & SOC n=10 Participants Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits brimonidine topical gel 0.33% \& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants	8 Participants n=10 Participants	18 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants
Sex: Female, Male Female	6 Participants n=6 Participants • Gender not collected for all participants	6 Participants n=6 Participants • Gender not collected for all participants	12 Participants n=12 Participants • Gender not collected for all participants
Sex: Female, Male Male	0 Participants n=6 Participants • Gender not collected for all participants	0 Participants n=6 Participants • Gender not collected for all participants	0 Participants n=12 Participants • Gender not collected for all participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) White	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Region of Enrollment United States	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants

PRIMARY outcome

Timeframe: 6 months

To assess adherence to topical brimonidine for the treatment of rosacea as measured by MEMS caps. The result will be the % of prescribed doses that were actually taken by the subject

Outcome measures

Outcome measures
Measure	Brimonidine Topical Gel 0.33% & Survey n=10 Participants Topical drug and standard of care follow-up,with weekly survey.	Brimonidine Topical Gel 0.33% & SOC n=10 Participants Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits brimonidine topical gel 0.33% \& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%
Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)	8.2 percentage of medication use Standard Deviation 5.3	6.9 percentage of medication use Standard Deviation 4.2

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months

Change in total Lesion count