Sansrosa starts Phase II strength tests, still a long way to go

Written by on October 3, 2009 in Galderma, Red Face of Rosacea, Sansrosa with 14 Comments

Sansrosa is continuing its very slow progress 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.

Galderma is now back at one of the Phase II tests for a new drug. This seems disappointing given that Phase 2 Trials were thought to completed in August 2007 and Phase III was slated to commence in early 2008. One can only speculate that Galderma wasn’t satisfied with the progress and likely success of sansrosa and has sent it back for further testing.

It has been a long slow process, but it is encouraging to see that Galderma is still investing in developing this much-awaited product.

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.

Update: the Dose-Finding has now completed. Note that these trials are part of the Phase II of development of sansrosa. Before a new drug can be approved by the FDA, Galderma must  conclude well-controlled Phase III trials and/or Long Term safety studies.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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14 Reader Comments

  1. Michael says:

    Does anybody know if Sansrosa will work for Keratosis Pilaris Rubra Faciei???

  2. 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.

  3. daniel says:

    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.

  4. DukeCity says:

    If you have inflammation regardless, it should dramatically reduce it. I just hope it’s released in 2010, it should be the best topical by far, imagine taking Oracea and using Sansrosa every day. It’s a goldmine for Galderma – but if it works like it’s touted to, then well worth every penny.

  5. Hi DukeCity,

    You are right in that Galderma appears set to reap the rewards from their investment in Rosacea R&D.

    Lets hope that they use those future profits to fund more novel research.

    davidp.

  6. El dictator says:

    davo, are we any closer to a release yet?
    Am I right in saying this is just for the constant and underlying redness/erythema?

  7. Nothing new to report, we are just sitting and waiting.

    Sansrosa will officially be targeted for the redness of rosacea, any other symptoms relieved will be a bonus.

    THE Dictactor,
    davidp.

  8. El dictator says:

    thanks davo,
    The mild to medium underlying redness and redness flare-ups / flushing is really what Im going for, so it sounds good and gives my mind a little relief that there’s something…
    Now whether it’ll work for myself or whether it’s coming to the u.k and will be prescribed by an nhs doctor is another matter

  9. Beavis says:

    I suffer from KPRF also (6 ipl treatments done 4 years from which I got good results ,but redness/flushing is back nearly as bad as ever ) . The over production of keratin seems to be what causes the blood vessel damage/growth in KPRF .Hopefully when sansrosa hits the market it will be helpfull to us KPRF sufferers also. Does anyone know will it be safe to use in the long term? Due to the nature of KP & the excess keratin production , the underlying problem will not be curtailed, only (hopefully) the redness/inflamation and long term usage will probobly be needed.

  10. Tom says:

    Hi Guys:

    Everything I had read indicated a possible release date this year. So is 2010 still a realistic target date or has the above info delayed it’s launch?

    Thanks!

  11. It seems clear to me given that the product is back at Phase II testing, it is highly unlikely that the Phase III testing can be completed and approval granted in 2010.

    Additionally, you would have to be a real optimist to believe 2011 is likely.

    davidp.

  12. George says:

    Hey all,

    I read in a different article that Galderma wanted to increase the dosage of sansrosa.

    Is it not possible that they have already started the phase 3 testing but because they feel that they may be able to offer a stronger dosage they have had to alter their stage 2 testing slightly to enable this to happen?

    Regards

    George

  13. George says:

    Cont:

    Also if Galderma thought there was a high chance of Sansrosa not succeeding in the tests why would they be looking at a higher dosage of the product?

    Maybe these are simply the steps they need to take to offer a higher dosage??

    George

  14. Sounds like a reasonable guess George. You might even be able to grow the market for this product by selling 3 strengths – splitting the users into 3 groups.

    All speculation of course, but it might also be just the Galderma wasn’t happy with the trials so far and themselves do things differently compared to how Collagenex and Sansrosa executed.

    davidp.

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