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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II systemic bioavailability crossover study to measure the exposure of Col-118 topical 0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2%

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Brimonidine Tartrate; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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