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

Information source: Galderma
ClinicalTrials.gov processed this data on August 20, 2015
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); Advanced Eye Relief (Drug); COL-118 facial gel vehicle (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Galderma

Official(s) and/or principal investigator(s):
James Leyden, M.D., Principal Investigator, Affiliation: KGL, Inc.

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: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Cmax - Maximum Systemic Concentration of Brimonidine

AUC - Area Under the Curve of Brimonidine

Tmax - Time to Maximum Plasma Concentration

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

KGL, Inc., Broomall, Pennsylvania 19008, United States
Additional Information

Starting date: May 2008
Last updated: August 6, 2014

Page last updated: August 20, 2015

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