News today of a parallel Sansrosa Phase III Trial.
This just announced trial is shorter than the Long Term (52 week) Safety Trial, and seeks to confirm that Sansrosa Gel (CD07805/47) is more effective than the inactive vehicle gel and is itself a safe treatment.
Trial ID: NCT01355458 (seems to be somewhat duplicated with NCT01355471)
Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea.
The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.
- Estimated Enrolment: 260
- Study Start Date: May 2011
- Estimated Study Completion Date: November 2011
- Estimated Primary Completion Date: October 2011
By comparison the Long Term Trial for Sansrosa lists 450 participants and is use to be complete in August 2012.
How is “Effective” Measured?
This trial will measure success as 1-grade improvement in redness after 30 minutes and a 2-grade improvement in facial redness at Day 29. The improvement is based on the assessment by both the clinician and the patient.
Exclusions
Interestingly if you have 3 or more facial lesions (i.e. a rosacea papule or pustule) you are ineligible for this trial.
