Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2%
Information source: Galderma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erythematous Rosacea
Intervention: 0.18% COL-118 facial gel (1.8 mg brimonidine) (Drug); 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Galderma Overall contact:
Barbara Gore, RN, BS, Phone: 609-860-8207, Email: barbara.gore@galderma.com
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%
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Bio-availability Study
Primary outcome: To assess the relative bioavailability of 0.18% COL-118 facial gel and 0.2% brimonidine ophthalmic solution under conditions of maximum use in patients with moderate to severe erythematous rosacea.
Secondary outcome: To evaluate the safety of COL-118 administered topically as a facial gel in male and female subjects with moderate to severe erythematous rosacea
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Barbara Gore, RN, BS, Phone: 609-860-8207, Email: barbara.gore@galderma.com
KGL, Inc., Broomall, Pennsylvania 19008, United States; Recruiting
Joan Johnson, Phone: 610-544-1715, Email: JoanJohnson_KGL@comcast.net
Additional Information
Starting date: May 2008
Ending date: September 2008
Last updated: June 17, 2008
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