Phase II systemic bioavailability crossover study to measure the exposure of Col-118
topical 0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2%
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.
There will be at least a 1-day washout between dose administrations (Period 1 and Period 2).
Blood samples for PK analysis of brimonidine levels will be collected at the following time
points during Period 1 and Period 2: 0 Hour (prior to dose) and at 1, 2, 3, 4 (prior to 2nd
dose), 5, 6, 7, and 8 hours post-dose.
- Male or female ≥18 years of age
- Clinical diagnosis of rosacea
- A score of ≥ 3 on the CEAS
- A score of ≥ 3 on the PSA
- IOP ≥ 10 mm Hg
- Non-pregnant and non-lactating females
- History of hypersensitivity or allergies to any ingredient of the study drugs, unless
approved by the Investigator
- Use of brimonidine prescription medications within 14 days prior to Check-in
- Use of any over-the-counter (OTC), non-prescription preparations (including vitamins,
minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior
to Check-in, unless deemed acceptable by the Investigator
- Use of systemic or topical steroids applied to the face 14 days prior to Check in
- The use of any Rx or OTC products for the treatment of acne or rosacea within 14 days
prior to check in
- The use of isotretinoin within 180 days prior to check in