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.

Related Articles

• Read more of the comprehensive coverage of Sansrosa News
• Collagenex CEO says rebound not yet seen in Sansrosa
• COL-118/Sansrosa $150+ a month ?
• Sansrosa’s sister to enter redness race
• oxymetazoline good for 6 hours and safe for 3 months