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

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Erythematous Rosacea
Interventions
DRUG

0.18% COL-118 facial gel (1.8 mg brimonidine)

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 4 hours

DRUG

0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop)

One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) 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.

DRUG

Advanced Eye Relief

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 4 hours

DRUG

COL-118 facial gel vehicle

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

Trial Locations (1)

19008

KGL, Inc., Broomall

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Galderma R&D

INDUSTRY