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

Galderma

Status and phase: Completed; Phase 2

Conditions: Erythematous Rosacea

Treatments: Drug: 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop); Drug: 0.18% COL-118 facial gel (1.8 mg brimonidine); Drug: Advanced Eye Relief; Drug: COL-118 facial gel vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697541

COL-118-ROSE-202

RD.06.SPR.18126

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

A

Experimental group

Description:

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:

Drug: Advanced Eye Relief

Drug: 0.18% COL-118 facial gel (1.8 mg brimonidine)

B

Active Comparator group

Description:

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

Treatment:

Drug: COL-118 facial gel vehicle

Drug: 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop)