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Internet Surveys and Their Impact on Adherence for Rosacea

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ClinicalTrials.gov Identifier: NCT03048058
Recruitment Status : Completed
First Posted : February 9, 2017
Results First Posted : August 13, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Other
Condition Rosacea
Interventions Drug: brimonidine topical gel 0.33% & survey
Drug: brimonidine topical gel 0.33% & SOC
Enrollment 20
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Hide Arm/Group Description

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,

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%

Period Title: Overall Study
Started 10 10
Completed 6 6
Not Completed 4 4
Reason Not Completed
Lost to Follow-up             4             0
Withdrawal by Subject             0             4
Arm/Group Title Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC Total
Hide Arm/Group Description

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,

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 of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
20 subjects of both genders 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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
8
  80.0%
18
  90.0%
>=65 years
0
   0.0%
2
  20.0%
2
  10.0%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
6
 100.0%
6
 100.0%
12
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Gender not collected for all participants
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
10
 100.0%
10
 100.0%
20
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10
 100.0%
10
 100.0%
20
 100.0%
1.Primary Outcome
Title Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)
Hide Description 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
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Hide Arm/Group Description:
Topical drug and standard of care follow-up,with weekly survey.

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 Number of Participants Analyzed 10 10
Median (Standard Deviation)
Unit of Measure: percentage of medication use
8.2  (5.3) 6.9  (4.2)
2.Secondary Outcome
Title Lesion Count
Hide Description Change in total Lesion count
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months
Arm/Group Title Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Hide Arm/Group Description:
Topical drug and standard of care follow-up,with weekly survey.

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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: count of lesions
Baseline Number Analyzed 10 participants 10 participants
4  (9.6) 10.4  (17.6)
6 Months Number Analyzed 7 participants 6 participants
2.7  (2.9) 6.2  (6.7)
3.Secondary Outcome
Title Clinician Erythema Assessment Scale
Hide Description Clinician Erythema Assessment scale based on scale of 0-4 with 0 being no erythema and 4 being severe erythema with greater scores denoting a worse outcome.
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months
Arm/Group Title Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Hide Arm/Group Description:
Topical drug and standard of care follow-up,with weekly survey.

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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 10 participants 10 participants
2.4  (0.5) 2.5  (.53)
6 Months Number Analyzed 7 participants 6 participants
2.7  (2.8) 2.3  (.52)
4.Secondary Outcome
Title Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)
Hide Description Change in overall Quality of Life as measured by the The Life Impact Survey. This measures the impact of rosacea and its treatment on life. The score range is 0-54 with higher scores denoting worse outcomes.
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months
Arm/Group Title Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Hide Arm/Group Description:
Topical drug and standard of care follow-up,with weekly survey.

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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 10 participants 10 participants
2.4  (2.12) 6.2  (8.66)
6 Months Number Analyzed 7 participants 6 participants
1.43  (1.72) 1.5  (1.05)
5.Secondary Outcome
Title Patient Severity Assessment (PSA)
Hide Description Patient Severity Assessment: Subject ratings of erythema with scale 0 - 4. 0 = face free of rosacea; 4 = My face has severe medium to large sized red inflamed bumps or pustules, My face has severe redness. Higher scores denotes worse outcomes.
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months
Arm/Group Title Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Hide Arm/Group Description:
Topical drug and standard of care follow-up,with weekly survey.

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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 9 participants 10 participants
1.6  (0.7) 2.4  (1.26)
6 Months Number Analyzed 7 participants 6 participants
1.14  (.9) 1.17  (.98)
6.Secondary Outcome
Title Quality of Life With Rosacea
Hide Description Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes.
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months
Arm/Group Title Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Hide Arm/Group Description:
Topical drug and standard of care follow-up,with weekly survey.

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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 10 participants 10 participants
17.5  (4.25) 13.7  (4.79)
6 Months Number Analyzed 7 participants 6 participants
15.57  (4.35) 13  (4.1)
7.Secondary Outcome
Title Dermatology Life Quality Index
Hide Description Dermatology Life Quality Index (DLQI) for the impact of rosacea on everyday activities. The score range is 0-30 with higher scores having a larger effect on patient's life.
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected
Arm/Group Title Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Hide Arm/Group Description:
Topical drug and standard of care follow-up,with weekly survey.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Hide Arm/Group Description brimonidine topical gel 0.33% & survey adverse events Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits
All-Cause Mortality
Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brimonidine Topical Gel 0.33% & Survey Brimonidine Topical Gel 0.33% & SOC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Limitations: small sample size (n=20) and poor subject retention. With limited patient data, particularly due to loss of patient follow up, the power of the study was less than ideal.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Irma M. RIchardson, MHA;
Organization: Wake Forest University Health Sciences
Phone: 336-716-2903
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03048058     History of Changes
Obsolete Identifiers: NCT02659670
Other Study ID Numbers: 00036221
First Submitted: February 6, 2017
First Posted: February 9, 2017
Results First Submitted: June 29, 2018
Results First Posted: August 13, 2018
Last Update Posted: October 10, 2018