Erythemato-telangiectatic Rosacea
Conditions
Keywords
BFH772, rosacea, erythemato-telangiectatic rosacea
Brief summary
This study will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of treatment as compared to an active control and vehicle in patients with erythemato-telangiectatic rosacea.
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Have persistent facial erythema on the cheeks of at least moderate severity. * Women must not be able to bear children
Exclusion criteria
* Have more than 12 inflammatory lesions on the face * Previous treatment of facial skin with lasers or electrocauterisation within 2 months prior to entering the study * Have facial hair that makes it difficult to evaluate rosacea on the face Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of BFH772 treatment compared to vehicle on non-transient facial erythema using the Investigator's assessment of facial erythema score | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate a patient's assessment of flushing frequency via patient reported episodes and facial redness via a patient reported score | 12 weeks |
| To measure blood levels of BFH772 in patients | 12 weeks |
Countries
United States
Outcome results
None listed