A new Phase 3 Efficacy and Safety study of Sansrosa (CD07805/47 Topical Gel) has been listed by Galderma. These trials are to confirm the safety and performance of CD7805/47 in treating the redness of rosacea.
The trial will assess the effectiveness of Sansrosa after 29 days and also on how the patient sees the benefit after 30 minutes. Both measures will look for a 1-grade improvement in facial redness.
Interestingly these trials are to be conducted at 6 sites in Russia and 1 in Sweden. The cities listed are Chelyabinsk, Ekaterinburg, Moscow, Saint Petersburg, Saratov and Eskiltuna. Up to 110 rosacea redness sufferers will be studied.
This trial confirms that the Phase 3 Trial period of Sansrosa continues.
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema of Rosacea
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 Enrollment: 110
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013
Primary Outcome Measures:
- Composite Success Assessment (CEA) and Patient Self Assessment(PSA). [ Time Frame: Day 29 ]
Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
Secondary Outcome Measures:
- Composite Success Assessment (CEA) and Patient Self Assessment(PSA). [ Time Frame: D1 ]
30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.
- DT: Sansrosa 0.5% Better than 0.18% Twice a Day
- Comparing Sansrosa to Finacea for Redness
- Combine Brimonidine and Oxymetazoline, Why Not?
- Sansrosa Completes Phase III Trials
- Sansrosa Phase II Results at 2012 AAD San Diego
- Sansrosa not Susceptible to Tolerance or Rebound
- Final FDA Approval of Sansrosa, expect 15 months post Phase III