Sansrosa Gel versus Eyes Drops Absorption Trial

Written by on June 17, 2008 in clinical trials, Sansrosa with 7 Comments

The Clinical Trial register is showing details for the bio-availabilty trial for COL-118/Sansrosa. This Phase 2 trial aims to compare the amount of the active ingredient that is bio-available when the newly formulated gel is used on rosacea skin, and when used as eye drops.

This announcement appears to be the extra trial asked for by the FDA who are concerned that rosacea skin may allow more systemic absorption than non rosacea skin. The side effects of Brimonidine when it gets into your blood are extremely dangerous. Even though the Phase 1 trials of COL-118 showed that healthy volunteers did not have measurable quantities of the active ingredient, diseased rosacea skin may allow more of the Brimonidine to enter the blood stream.

The bit that is new in this trial is that all of the participants will have moderate to severe erythematous rosacea and use the brimonidine ophthalmic solution. The group will be split randomly such that 1/2 will use the new Sansrosa Gel and 1/2 will use the inactive vehicle. The amount of the active ingredient in the blood plasma will be compared between the 2 groups. For the product to proceed to the next step, there will need to be no measurable difference.

The larger scale Phase 3 safety trials have been delayed until after this Phase 2 trial is completed in September this year.

From Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2%

Primary Outcome Measures:
To assess the relative bioavailability of 0.18% COL-118 facial gel and 0.2% brimonidine ophthalmic solution under conditions of maximum use in patients with moderate to severe erythematous rosacea.

Secondary Outcome Measures:
To evaluate the safety of COL-118 administered topically as a facial gel in male and female subjects with moderate to severe erythematous rosacea

Detailed Description:

A double-blind, randomized, 2-way crossover, safety, pharmacokinetic/-dynamic (PK/PD) study of 0.18% COL-118 facial gel and 0.2% brimonidine ophthalmic solution administered in male and female patients with moderate to severe erythematous rosacea.

Twenty male and female subjects with moderate to severe erythematous rosacea will be randomized into 2 groups of 10 subjects.

Each group will be randomized to receive 2 treatments (Treatments A and B, in Sequence 1: A/B or Sequence 2: B/A), as follows:

Treatment A: One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after four hours;

Treatment B: One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically.

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Read more about: clinical trials, Sansrosa

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

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7 Reader Comments

  1. Ben says:

    awesome find! I have to say that, even after following this drug for apr 4 years, I am still a little confused by the study parameters on this one…
    for instance, I don’t get how the Advanced Eye Relief comes into play here…

  2. Ben says:

    So, if I am reading this correctly, 10 will be taking the vehicle on the face and the real eye drops, while the other 10 will be taking the vehicle eye drops and the real gel on the face…
    BTW, it is the first time I have ever heard Sansrosa referred to as a “gel”

  3. Hi Ben,

    A good question. The Advanced Eye Relief is just a glycerin based eye drop. It is used as the placebo so that participants don’t know whether they are using the real Alphagan P or not. Participants will receive treatment A and at another time treatment B. There should be no statistical difference between those receiving A or B when measuring the blood serum levels of brimonidine tartrate.

    This being the case, then it can be shown that rosacea skin is not more prone to absorbing brimonidine tartrate through the skin compared to normal skin – and safe compared to using the Alphagan P eye drops.

    davidp.

  4. Yes it is also the first time that I have seen Sansrosa referred to as “0.18% COL-118 facial gel”. Alphgan P is 0.20%, so for some reason the gel is formulated with a slightly lower resulting concentration.

    davidp.

  5. Ben says:

    Anyone live in Philadelphia area? If so, you might have a chance to get in on this trial!!!

  6. portillion posted in the sansrosa update thread (http://rosacea-support.org/community/posting.php?mode=reply&f=5&t=412#pr5001) that this trial was already full. Only 20 participants so it looks like it filled quickly.

  7. Cary Anderson says:

    Hi, when is this treatment going to be available? it seems as though the trials have been going on for a really long time.

    thanks, Cary

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