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

• Sponsor: Derm Research, PLLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT02147691
• Collaborator: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma (Industry)
• Enrollment: 22
• Location: 1
• Arms: 2
• Duration (Months): 9.1
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The pilot study will investigate whether combination treatment of Finacea 15% Gel and Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in treating both the papules/pustules and erythema associated with rosacea.

Condition or Disease	Intervention/Treatment	Phase
Acne Rosacea	Drug: Azelaic acid 15%; Drug: Brimonidine 0.33%	Phase 4

Detailed Description

Acne rosacea is a chronic inflammatory disease with different components including inflammatory lesions (papules/pustules), erythema and telangiectasia. Brimonidine 0.33% Gel primarily affects the erythematous components of rosacea. As such, combination treatment with a standard rosacea treatment, such as Finacea 15% Gel, may provide additional relief for the inflammatory component of rosacea.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Azelaic acid 15%, Brimonidine 0.33 % Gel Azelaic acid 15% to the face each AM followed 30 minutes later by Brimonidine 0.33% Azelaic acid 15% to the face each PM	Drug: Azelaic acid 15%; Applied to the face each AM and PM; Other Names: Finacea ; Drug: Brimonidine 0.33%; Applied to the face each AM 30 minutes after the application of Azelaic acid 15%; Other Names: Miravaso
Active Comparator: Brimonidine 0.33% Gel Brimonidine 0.33% Gel	Drug: Brimonidine 0.33%; Applied to the face each AM 30 minutes after the application of Azelaic acid 15%; Other Names: Miravaso

Outcome Measures

Primary Outcome Measures

1. Investigator Global Assessment (IGA) at Baseline [Baseline]

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

2. IGA [Week 4]

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

3. IGA [Week 8]

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

4. IGA [Week 12]

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

Secondary Outcome Measures

1. Lesion Counts [Baseline]

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

2. Clinician's Erythema Assessment [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.

3. Erythema Visual Analog Scale (VAS) Assessment (Subject) [Baseline]

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

4. Dermatology Life Quality Index (DLQI) [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.

5. Lesion Count [Week 4]

6. Lesion Counts [Week 8]

7. Lesion Counts [Week 12]

8. Erythema [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

9. Erythema [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

10. Erythema [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

11. Visual Analog Scale (VAS) [Week 4]

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

12. VAS [Week 8]

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

13. VAS [Week 12]

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

14. Dermatology Life Quality Index (DLQI) [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)

15. DLQI [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)

16. DLQI [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or Female

• 18 years of age and older

• Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline

• Female subjects of childbearing potential must practice a reliable method of contraception throughout the study

• Moderate or severe rosacea with an Investigator Global Assessment (IGA) score of 3 or 4

• Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization forms

Exclusion Criteria:

• Female subjects who are pregnant, breast feeding or who are of childbearing potential and not practicing a reliable method of birthcontrol

• History of hypersensitivity or idiosyncratic reaction to any component of the test medications

• Subjects who have not completed the proper wash-out periods for prohibited medications and/or procedures

• Medical condition that contraindicates the subject's participation in the study

• Alcohol or drug abuse is evident within the past 5 years

• History of poor cooperation, non-compliance with medical treatment, unreliability

• Participation in an investigational drug study within 30 days of the Baseline visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DermResearch, PLLC	Louisville	Kentucky	United States	40217

Sponsors and Collaborators

• Derm Research, PLLC
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Investigators

• Principal Investigator: Leon H. Kircik, M.D., DermResearch, PLLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leon Kircik, M.D., Medical Director, Derm Research, PLLC
• ClinicalTrials.gov Identifier: NCT02147691
• Other Study ID Numbers: FIN1302
• First Posted: May 28, 2014
• Last Update Posted: Sep 30, 2015
• Last Verified: Aug 1, 2015

• Additional relevant MeSH terms: Rosacea; Azelaic acid; Brimonidine Tartrate

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 0.33 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidine 0.33%
Period Title: Overall Study
STARTED	10	12
COMPLETED	6	11
NOT COMPLETED	4	1

Baseline Characteristics

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel	Total
Arm/Group Description	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 applied to the face each morning Brimonidine 0.33%	Total of all reporting groups
Overall Participants	10	12	22
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 60%	11 91.7%	17 77.3%
>=65 years	4 40%	1 8.3%	5 22.7%
Sex: Female, Male (Count of Participants)
Female	9 90%	9 75%	18 81.8%
Male	1 10%	3 25%	4 18.2%

Outcome Measures

1. Primary Outcome

Title	Investigator Global Assessment (IGA) at Baseline
Description	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	3 (0)	3.1 (0.3)

2. Secondary Outcome

Title	Lesion Counts
Description	The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [lesions]	3.3 (1.6)	4.5 (2.8)

3. Secondary Outcome

Title	Clinician's Erythema Assessment
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	2.3 (0.5)	2.1 (0.3)

4. Secondary Outcome

Title	Erythema Visual Analog Scale (VAS) Assessment (Subject)
Description	Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	5.5 (2.5)	5.6 (1.8)

5. Secondary Outcome

Title	Dermatology Life Quality Index (DLQI)
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	2.6 (3.7)	2.9 (1.9)

6. Primary Outcome

Title	IGA
Description	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	1.8 (0.9)	1.8 (0.8)

7. Primary Outcome

Title	IGA
Description	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	1.6 (1.2)	1.8 (0.9)

8. Primary Outcome

Title	IGA
Description	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	1.3 (1.1)	1.4 (0.9)

9. Secondary Outcome

Title	Lesion Count
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [lesions]	1.1 (1.2)	2.1 (2.9)

10. Secondary Outcome

Title	Lesion Counts
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [lesions]	1.0 (1.4)	1.7 (2.1)

11. Secondary Outcome

Title	Lesion Counts
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [lesions]	0.7 (1.3)	1.2 (1.3)

12. Secondary Outcome

Title	Erythema
Description	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
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	1.6 (0.7)	1.3 (0.7)

13. Secondary Outcome

Title	Erythema
Description	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
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	1.3 (0.8)	1.4 (0.7)

14. Secondary Outcome

Title	Erythema
Description	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
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	1.3 (0.7)	1.2 (0.8)

15. Secondary Outcome

Title	Visual Analog Scale (VAS)
Description	participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	4.5 (2.4)	5.2 (2.1)

16. Secondary Outcome

Title	VAS
Description	participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	4.4 (3.0)	4.5 (2.1)

17. Secondary Outcome

Title	VAS
Description	participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	3.8 (2.3)	4.0 (2.1)

18. Secondary Outcome

Title	Dermatology Life Quality Index (DLQI)
Description	Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	1.8 (1.5)	2.6 (2.0)

19. Secondary Outcome

Title	DLQI
Description	Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	1.3 (1.2)	2.6 (2.6)

20. Secondary Outcome

Title	DLQI
Description	Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel	Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
Measure Participants	6	11
Mean (Standard Deviation) [units on a scale]	1.2 (1.2)	2.8 (2.8)

Adverse Events

Arm/Group Title	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel		Brimonidine 0.33% Gel
Arm/Group Description	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 applied to the face each morning Brimonidone 0.33%
All Cause Mortality
	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel		Brimonidine 0.33% Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel		Brimonidine 0.33% Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel		Brimonidine 0.33% Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/10 (30%)		4/12 (33.3%)
Musculoskeletal and connective tissue disorders
pulled muscle	0/10 (0%)	0	1/12 (8.3%)	1
Broken toe	1/10 (10%)	1	0/12 (0%)	0
Renal and urinary disorders
urinary tract infection	1/10 (10%)	1	0/12 (0%)	0
Respiratory, thoracic and mediastinal disorders
common cold	1/10 (10%)	1	0/12 (0%)	0
sinus infection	1/10 (10%)	1	0/12 (0%)	0
bronchitis	1/10 (10%)	1	0/12 (0%)	0
pneumonia	1/10 (10%)	1	0/12 (0%)	0
Skin and subcutaneous tissue disorders
worsening erythema on face	0/10 (0%)	0	1/12 (8.3%)	1
worsening facial lesions	0/10 (0%)	0	1/12 (8.3%)	1
herpes simplex	0/10 (0%)	0	1/12 (8.3%)	1
burning at application site	1/10 (10%)	1	0/12 (0%)	0

Limitations/Caveats

Pilot study. Small number of participants.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.