Galderma sends Sansrosa backwards – Phase 2 Dosage Trials Again

Written by on August 4, 2010 in Galderma, Sansrosa with 8 Comments

In yet more proof that Galderma wants to sit on the drug known as Sansrosa, a new August 2010 Phase II dose finding study has been listed at clinicaltrials.gov.

This latest trial will compare Sansrosa, or CD07805/47 as Galderma now calls it, in strengths of 0.5% and 0.18% against a placebo containing just the vehicle gel. A total of 260 patients will be studied with an estimated primary completion date of February 2011.

Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

Estimated Enrollment: 260

Study Start Date: August 2010

Estimated Study Completion Date: March 2011

Estimated Primary Completion Date: February 2011

The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.

This trial is in addition to the September 2009 trial covered by Rosacea News as Sansrosa starts Phase II strength tests, still a long way to go. That earlier dose-finding trial compared topical gel concentrations of 0.07%, 0.18% and 0.50% and involved 112 participants.

One could speculate from this just listed trial that Galderma is not impressed with the efficacy of CD07805/47 Gel at 0.07%.

It is well worth noting that Sansrosa is now firmly fixed back in Phase 2 trials, and the all important much larger Phase III trials cannot even be contemplated until at least the middle of 2011.

Since Galderma acquired Collagenex in February 2008, Sansrosa has only headed backwards in its development cycle. Galderma don’t seem to be in any rush to get this product to market. This is surprising as there is such a dearth of treatments for the redness of rosacea.

In June 2008 Collagenex tested topical Sansrosa 0.18% against Bromidine Ophthalmic 0.2% to compare systemic absorption of the active molecule.

Previous Phase 2 dose-finding trials by Collagenex, for COL-118, as they then called it, were made public as far back as August 2007  (see Sanrosa (COL-118) phase 2 looking promising).

Here we are 3 years later, and yet again this product is undergoing trials to determine the percentage of active ingredient that should be further developed.

Whilst it may be easy for those waiting for this product to become discouraged, it is a positive that we at least know that Galderma have the R&D dollars to see this product through. Of course this is itself predicated on Galderma continuing to believe that Sansrosa will become a viable product and make substantive returns for their shareholders.

Sansrosa; the never ending story.

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Read more about: Galderma, Sansrosa

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

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8 Reader Comments

  1. Doug says:

    UGH! Hopefully Signum gets it right with their product! Any updates on where they are at with their Rosacea product?

  2. David Pascoe says:

    Doug, I wouldn’t expect to hear even monthly updates on new product developments, things take much longer. I will be sure to post here whenever something new is available.

    davidp.

  3. Andre says:

    From what I understand, this drug that Galderma is studying works great. The reason that they are going backward is because they are a conservative company and seem to not be happy with the way the research was conducted the first time. We should be thankful that they are taking the right steps to make sure that a safe drug is brought to market, just look at some of the others that have been pulled lately for bad stuff.

  4. Tom says:

    I was holding out for Sansrosa but I can’t wait another few years. I have decided to try IPL. I hope it will keep the symptoms at bay until this or another of the medications currently in the pipeline do finally become available.

  5. j says:

    Sanrosa is such a tease 😛

  6. Michael says:

    @ Andre….

    “From what I understand, this drug that Galderma is studying works great”.

    I hope you are right.

  7. LA Rosaeca girl says:

    I am currently enrolled in the Sansrosa Phase II clinical trial in LA. Am very pleased with the results so far. I have been a rosaeca patient for years and have had very little luck finding something to help the redness. My understanding is that the Phase II should be complete by late winter. Then, it’s on to Phase III!

  8. David Pascoe says:

    Hi LA Rosacea Girl,

    Do you know for sure that you were on the active lotion, as opposed to the placebo?

    Also, it seems to me that those who run the trial don’t like to let on what is the active that they are trialling. This is interesting to me as there are oxymetazoline based trials for redness underway currently as well.

    davidp.

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