Trial Outcomes & Findings for Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea

Results Overview

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

Baseline

Results posted on

2015-09-30

Participant Flow

Single site recruitment, private medical clinic.. Subjects 18 to 85 years of age with moderate to severe rosacea.Recruitment began May 2014 and ended November 2014.

Subjects could be excluded if less than 18 years of age, who does not have moderate to severe rosacea as determined by the Investigator Global Assessment (IGA), who has not completed the specified washout for medications as outlined in the protocol or who has been in another investigational study within 30 days of the Baseline visit.

Participant milestones

Participant milestones
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 0.33 % Gel Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel Brimonidine 0.33% Gel applied to the face each morning Brimonidine 0.33%
Overall Study STARTED	10	12
Overall Study COMPLETED	6	11
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 0.33 % Gel Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel Brimonidine 0.33% Gel applied to the face each morning Brimonidine 0.33%
Overall Study Withdrawal by Subject	2	0
Overall Study Adverse Event	2	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=10 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=12 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidine 0.33%	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Only participants who were not lost to follow up or did not withdraw consent were included in the final analysis.

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Investigator Global Assessment (IGA) at Baseline	3 units on a scale Standard Deviation 0	3.1 units on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: Week 4

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
IGA	1.8 units on a scale Standard Deviation 0.9	1.8 units on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: Week 8

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
IGA	1.6 units on a scale Standard Deviation 1.2	1.8 units on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: Week 12

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
IGA	1.3 units on a scale Standard Deviation 1.1	1.4 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline

The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Lesion Counts	3.3 lesions Standard Deviation 1.6	4.5 lesions Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline

Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured.

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Clinician's Erythema Assessment	2.3 units on a scale Standard Deviation 0.5	2.1 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline

Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable)

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Erythema Visual Analog Scale (VAS) Assessment (Subject)	5.5 units on a scale Standard Deviation 2.5	5.6 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline

The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible.

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Dermatology Life Quality Index (DLQI)	2.6 units on a scale Standard Deviation 3.7	2.9 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Week 4

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Lesion Count	1.1 lesions Standard Deviation 1.2	2.1 lesions Standard Deviation 2.9

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Lesion Counts	1.0 lesions Standard Deviation 1.4	1.7 lesions Standard Deviation 2.1

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Lesion Counts	0.7 lesions Standard Deviation 1.3	1.2 lesions Standard Deviation 1.3

SECONDARY outcome

Timeframe: Week 4

Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Erythema	1.6 units on a scale Standard Deviation 0.7	1.3 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Week 8

Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Erythema	1.3 units on a scale Standard Deviation 0.8	1.4 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Week 12

Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Erythema	1.3 units on a scale Standard Deviation 0.7	1.2 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Week 4

participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Visual Analog Scale (VAS)	4.5 units on a scale Standard Deviation 2.4	5.2 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Week 8

participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
VAS	4.4 units on a scale Standard Deviation 3.0	4.5 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Week 12

participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
VAS	3.8 units on a scale Standard Deviation 2.3	4.0 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Week 4

Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Dermatology Life Quality Index (DLQI)	1.8 units on a scale Standard Deviation 1.5	2.6 units on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Week 8

Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
DLQI	1.3 units on a scale Standard Deviation 1.2	2.6 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Week 12

Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)

Outcome measures

Outcome measures
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=6 Participants Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=11 Participants Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
DLQI	1.2 units on a scale Standard Deviation 1.2	2.8 units on a scale Standard Deviation 2.8

Adverse Events

Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Brimonidine 0.33% Gel

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel n=10 participants at risk Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33%	Brimonidine 0.33% Gel n=12 participants at risk Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33%
Musculoskeletal and connective tissue disorders pulled muscle	0.00% 0/10	8.3% 1/12 • Number of events 1
Musculoskeletal and connective tissue disorders Broken toe	10.0% 1/10 • Number of events 1	0.00% 0/12
Skin and subcutaneous tissue disorders worsening erythema on face	0.00% 0/10	8.3% 1/12 • Number of events 1
Skin and subcutaneous tissue disorders worsening facial lesions	0.00% 0/10	8.3% 1/12 • Number of events 1
Renal and urinary disorders urinary tract infection	10.0% 1/10 • Number of events 1	0.00% 0/12
Respiratory, thoracic and mediastinal disorders common cold	10.0% 1/10 • Number of events 1	0.00% 0/12
Respiratory, thoracic and mediastinal disorders sinus infection	10.0% 1/10 • Number of events 1	0.00% 0/12
Skin and subcutaneous tissue disorders herpes simplex	0.00% 0/10	8.3% 1/12 • Number of events 1
Skin and subcutaneous tissue disorders burning at application site	10.0% 1/10 • Number of events 1	0.00% 0/12
Respiratory, thoracic and mediastinal disorders bronchitis	10.0% 1/10 • Number of events 1	0.00% 0/12
Respiratory, thoracic and mediastinal disorders pneumonia	10.0% 1/10 • Number of events 1	0.00% 0/12

Additional Information

Leon H. Kircik, M.D.

DermResearch, PLLC

Phone: 502-451-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Trial Outcomes & Findings for Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study (NCT NCT02147691)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

PRIMARY outcome

Outcome measures

PRIMARY outcome

Outcome measures

PRIMARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

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SECONDARY outcome

Outcome measures

SECONDARY outcome

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SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

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SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

Adverse Events

Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel

Brimonidine 0.33% Gel

Serious adverse events

Other adverse events

Additional Information

Leon H. Kircik, M.D.

Results disclosure agreements