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

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00697541

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%

Condition	Intervention	Phase
Erythematous Rosacea	Drug: 0.18% COL-118 facial gel (1.8 mg brimonidine) Drug: 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Bio-availability Study
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

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Brimonidine Brimonidine tartrate

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

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. [ Time Frame: 0 Hour (prior to dose) and at 1, 2, 3, 4 (just prior to the 2nd dose), 5, 6, 7, and 8 hours post-morning dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety of COL-118 administered topically as a facial gel in male and female subjects with moderate to severe erythematous rosacea [ Time Frame: at Screening and at specified times during the study, and/or at Study Completion ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	May 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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	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
B: Active Comparator 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	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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697541

Locations

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

Sponsors and Collaborators

Galderma

More Information

No publications provided

Responsible Party:	Galderma ( Michael Graeber, MD, Head of US Development )
Study ID Numbers:	COL-118-ROSE-202, RD.06.SPR.18126
Study First Received:	June 12, 2008
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00697541 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Galderma:

erythematous rosacea
facial gel
brimonidine
ophthalmic solution

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Skin Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents

Antihypertensive Agents
Adrenergic Agonists
Pharmacologic Actions
Rosacea
Therapeutic Uses
Brimonidine

ClinicalTrials.gov processed this record on November 05, 2009