Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00697541
Recruitment Status : Completed
First Posted : June 16, 2008
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma

Tracking Information
First Submitted Date  ICMJE June 12, 2008
First Posted Date  ICMJE June 16, 2008
Results First Submitted Date  ICMJE September 19, 2013
Results First Posted Date  ICMJE August 7, 2014
Last Update Posted Date August 7, 2014
Study Start Date  ICMJE May 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2014)
  • Cmax - Maximum Systemic Concentration of Brimonidine [ Time Frame: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose ]
    Maximum observed plasma concentration
  • AUC - Area Under the Curve of Brimonidine [ Time Frame: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose ]
    Area under the plasma concentration-time curve from 0 hour to the last measurable plasma concentration, calculated by the linear trapezoidal method After two topical applications of 0.18% COL-118 facial gel, plasma levels of brimonidine for all subjects were below the LoQ (25 pg/mL), with the exception of one single outlier value. Thus, no PK analysis could be performed for 0.18% COL-118 facial gel. After ocular administration of 0.2% brimonidine tartrate ophthalmic solution, quantifiable plasma concentrations of brimonidine were observed in 11 of the 18 subjects who received the brimonidine tartrate ophthalmic solution. Brimonidine rapidly appeared in plasma The mean Cmax was not calculated because values were not quantifiable for 7 of 18 subjects The mean AUC0-t also was not calculated.
  • Tmax - Time to Maximum Plasma Concentration [ Time Frame: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose ]
    time to maximum plasma concentration
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2008)
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 ]
Change History Complete list of historical versions of study NCT00697541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2%
Official Title  ICMJE 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
Brief 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%
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Erythematous Rosacea
Intervention  ICMJE
  • 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
    Other Name: brimonidine
  • 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.
    Other Name: brimonidine tartrate/drop
  • Drug: Advanced Eye Relief
    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
  • Drug: COL-118 facial gel vehicle
    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
Study Arms  ICMJE
  • Experimental: 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
    Interventions:
    • Drug: 0.18% COL-118 facial gel (1.8 mg brimonidine)
    • Drug: Advanced Eye Relief
  • Active Comparator: 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
    Interventions:
    • Drug: 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop)
    • Drug: COL-118 facial gel vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2008)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00697541
Other Study ID Numbers  ICMJE COL-118-ROSE-202
RD.06.SPR.18126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma
Study Sponsor  ICMJE Galderma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Leyden, M.D. KGL, Inc.
PRS Account Galderma
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP