Internet Surveys and Their Impact on Adherence for Rosacea

NCT03048058 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 00036221
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

An investigator-blinded, prospective, 6 month study of subjects with persistent erythema associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to apply it once daily per package insert. Adherence will be assessed using weekly internet surveys to document how often the medication is being used, as well as reminders about rosacea triggers and general use of brimonidine.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)

  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

  6 months

Secondary Outcomes (6)

• Lesion Count

  Baseline and 6 months

• Clinician Erythema Assessment Scale

  baseline and 6 months

• Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)

  baseline and 6 months

• Patient Severity Assessment (PSA)

  baseline and 6 months

• Quality of Life With Rosacea

  baseline and 6 months

Study Arms (2)

brimonidine topical gel 0.33% & survey

EXPERIMENTAL

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.

Drug: brimonidine topical gel 0.33% & survey; Drug: brimonidine topical gel 0.33% & SOC

brimonidine topical gel 0.33% & SOC

ACTIVE COMPARATOR

Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits

Drug: brimonidine topical gel 0.33% & SOC

Interventions

brimonidine topical gel 0.33% & survey DRUG

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.

Also known as: MIRVASO

brimonidine topical gel 0.33% & survey

brimonidine topical gel 0.33% & SOC DRUG

All subjects will receive standard-of-care brimonidine topical gel 0.33%

Also known as: Mirvaso

brimonidine topical gel 0.33% & SOC; brimonidine topical gel 0.33% & survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject with persistent erythema associated with rosacea, age greater than 18, who agrees to participate and provide written consent.
• Have an Investigator Global Assessment of mild to moderate rosacea (IGA rating between 2 and 5 in the Investigator Global Assessment score which includes erythema in the assessment).
• Access to a computer and the internet.

You may not qualify if:

• Initiation or change in dose within 4 weeks of baseline of systemic anti-inflammatory medication which may influence study outcome.
• Use of topical therapy for rosacea within 2 weeks of baseline.
• Use of systemic corticosteroids within 4 weeks of baseline. Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
• Subjects with known allergy or sensitivity to bromonidine topical gel, 0.33% or components therein.
• Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
• Subjects with severe cardiovascular disease or vascular insufficiency.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Dept of Dermatology, WFUHS

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Surveys and Questionnaires; Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Irma M. RIchardson, MHA
• Organization: Wake Forest University Health Sciences

irichard@wakehealth.edu

336-716-2903

Study Officials

• Steve Feldman, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 9, 2017
• Study Start: May 5, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 10, 2018
• Results First Posted: August 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)