Phase 4
Completed N=20
Internet Surveys and Their Impact on Adherence for Rosacea
Source: ClinicalTrials.gov NCT03048058 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Adherence (% of Prescribed Doses That Were Actually Taken by the Subject) — 8.2; 6.9 percentage of medication use
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence (% of Prescribed Doses That Were Actually Taken by the Subject) |
8.2; 6.9 | — |
| SECONDARY Lesion Count |
4; 10.4; 2.7; 6.2 | — |
| SECONDARY Clinician Erythema Assessment Scale |
2.4; 2.5; 2.7; 2.3 | — |
| SECONDARY Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities) |
2.4; 6.2; 1.43; 1.5 | — |
| SECONDARY Patient Severity Assessment (PSA) |
1.6; 2.4; 1.14; 1.17 | — |
| SECONDARY Quality of Life With Rosacea |
17.5; 13.7; 15.57; 13 | — |
| SECONDARY Dermatology Life Quality Index |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03048058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.