In an encouraging sign that Sansrosa is slowly but surely progressing towards FDA approval, the clinicaltrials.gov register lists Galderma recruiting for a dose-finding trial for a product code named CD07805/47.
The aim of this trial is show which strength is the most suitable for general use. Trial participants will be using one of 4 different strengths: 0.07%, 0.18%, %0.50 or effectively %0 contained in the gel vehicle. This trial should be completed by the end of the year, paving the way for an eagerly anticipated FDA approval in 2010.
Rosacea News previously found a patent application listing the full ingredients for Sansrosa, which included a mention of the active ingredient Brimonidine tartrate at a concentration of 0.18%. This trial suggests that Galderma is now also interested in a almost 3 times as strong version of %0.50.
The trial details again confirm that Sansrosa is to be applied once per day and that benefits can be expected for up to 12 hours after application. The patent related to the Sanrosa product itself suggested that typical usage was 1-4 times per day.
Galderma is looking for 112 participants, and the register suggests that residents of Pennsylvania, Texas, Virginia and Arkansas are eligible. Please do post below if you get to be a part of this final phase of testing.
Galderma acquired the Sansrosa product through their acquisition of Collagenex. Rosacea News has been following this product for several years now, since Collagenex first started talking about a new product COL-118, in 2006. It appears that Galderma is approaching the final hurdle before being able to ask the FDA for permission to sell their product. It has been a long slow process, but it is encouraging to see this potential redness treatment reaching the end of the approvals process.
Read more of my extensive coverage of Sansrosa News.
Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.
3 comments ↓
Does anybody know if Sansrosa will work for Keratosis Pilaris Rubra Faciei???
Hi Michael, in all the discussions of this product I haven’t seen any discussion of it being used for anything other than the redness of rosacea, sorry.
yeah i am not sure if i have rosacea or KPRF, two of my derms say rosacea, i even mentioned my arms to one of them because i have kp and she knew right off that bat that i had kp so i would assume she would know what kprf is too. Anyways, i do hope, and from my understanding, sansrosa will work for facial redness, which occurs in both rosacea and kprf.
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