Status:
COMPLETED
Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2%
Lead Sponsor:
Galderma R&D
Conditions:
Erythematous Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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%
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00697541
Start Date
May 1 2008
End Date
June 1 2008
Last Update
February 18 2021
Active Locations (1)
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1
KGL, Inc.
Broomall, Pennsylvania, United States, 19008