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

Completed · Phase 2

Conditions studied: Erythematous Rosacea

In brief

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

Key facts

Study ID

NCT00697541

Run by

Galderma R&D

People needed

20

Starts

2008-05-01

Expected to finish

2008-06-01

Last updated by the study team

2021-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• KGL, Inc. — Broomall, Pennsylvania, United States

Full record on ClinicalTrials.gov

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