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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Erythematous Rosacea
Interventions Drug: 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
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops
Hide Arm/Group Description

One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.

First intervention (1 day), washout (1 day), Second intervention (1 day)

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

First intervention (1 day), washout (1 day), Second intervention (1 day)

Period Title: Overall Study
Started 10 10
Completed 8 9
Not Completed 2 1
Arm/Group Title Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops Total
Hide Arm/Group Description

One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.

First intervention (1 day), washout (1 day), Second intervention (1 day)

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

First intervention (1 day), washout (1 day), Second intervention (1 day)

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
43.0  (8.5) 47.1  (6.7) 45.1  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
10
 100.0%
10
 100.0%
20
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Cmax - Maximum Systemic Concentration of Brimonidine
Hide Description Maximum observed plasma concentration
Time Frame 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A - COL-118 Facial Gel + Saline Drops Treatment B - Vehicle Gel + Brimonidine Drops
Hide Arm/Group Description:
COL-118 facial gel + saline drops
Vehicle gel + brimonidine drops
Overall Number of Participants Analyzed 19 18
Mean (Full Range)
Unit of Measure: pg/mL
NA [1] 
(NA to NA)
NA [2] 
(NA to 100)
[1]
After application of Brimonidine 0.18% Gel, plasma levels of brimonidine for all subjects were below the limit of quantification (< 25 pg/mL) with the exception of one single outlier value therefore no PK analysis could be performed.
[2]
The mean Cmax was not calculated because values were not quantifiable for 7 of 18 subjects.
2.Primary Outcome
Title AUC - Area Under the Curve of Brimonidine
Hide Description

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.

Time Frame 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A - COL-118 Gel + Saline Drops Treatment B - Vehicle Gel + Brimonidine Drops
Hide Arm/Group Description:
COL-118 gel + saline drops
Vehicle gel + brimonidine drops
Overall Number of Participants Analyzed 19 18
Mean (Full Range)
Unit of Measure: pg*hr/mL
NA [1] 
(NA to NA)
NA [2] 
(NA to 471)
[1]
After application of Brimonidine 0.18% Gel, plasma levels of brimonidine for all subjects were below the limit of quantification (< 25 pg/mL) with the exception of one single outlier value therefore no PK analysis could be performed.
[2]
The mean AUC was not calculated because values were not quantifiable for 9 of 18 subjects
3.Primary Outcome
Title Tmax - Time to Maximum Plasma Concentration
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A - COL-118 Facial Gel + Saline Drops Treatment B - Vehicle Gel + Brimonidine Drops
Hide Arm/Group Description:
COL-118 facial gel + saline drops
Vehicle gel + brimonidine drops
Overall Number of Participants Analyzed 19 18
Mean (Full Range)
Unit of Measure: Hours
NA [1] 
(NA to NA)
NA [2] 
(0.933 to 4.07)
[1]
After application of Brimonidine 0.18% Gel, plasma levels of brimonidine for all subjects were below the limit of quantification (< 25 pg/mL) with the exception of one single outlier value therefore no PK analysis could be performed.
[2]
After ocular administration of the 0.2% brimonidine tartrate ophthalmic solution, quantifiable plasma concentrations were observed in 11 of the 18 subjects, therefore Tmax Mean is NA.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description COL-118 gel + saline drops Vehicle gel + brimonidine drops
All-Cause Mortality
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   3/19 (15.79%)   7/18 (38.89%) 
Nervous system disorders     
Headache  3/19 (15.79%)  5/18 (27.78%) 
Syncope  0/19 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
pharyngolagyngeal pain  0/19 (0.00%)  1/18 (5.56%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Graeber, MD
Organization: Galderma
Phone: 609-860-8201
EMail: michael.graeber@galderma.com
Layout table for additonal information
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00697541     History of Changes
Other Study ID Numbers: COL-118-ROSE-202
RD.06.SPR.18126
First Submitted: June 12, 2008
First Posted: June 16, 2008
Results First Submitted: September 19, 2013
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014