Expired Study
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Broomall, Pennsylvania 19008


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00697541


Primary Contact:

Principal Investigator
James Leyden, M.D.
KGL, Inc.


Backup Contact:

N/A


Location Contact:

Broomall, Pennsylvania 19008
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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