Clinical trial NCT00697541: Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2%
Official title: A Phase II, Single-Center, Two-Way Crossover Relative Systemic Bioavailability Study of Col-118 Administered Topically as a 0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2% Administered to the Eye in Subjects With Moderate to Severe Erythematous Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erythematous Rosacea
Keywords: erythematous rosacea
facial gel
brimonidine
ophthalmic solution
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Cmax - Maximum Systemic Concentration of Brimonidine
timeFrame: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose
measure: AUC - Area Under the Curve of Brimonidine
timeFrame: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose
measure: Tmax - Time to Maximum Plasma Concentration
timeFrame: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose
Secondary outcomes:
Other outcomes:
Locations:
city: Broomall
country: United States
facility: KGL, Inc.
state: Pennsylvania
Study officials:
affiliation: KGL, Inc.
name: James Leyden, M.D.
role: PRINCIPAL_INVESTIGATOR
References: