Acne Rosacea
Conditions
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.
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.
Interventions
DRUGAzelaic acid 15%
Applied to the face each AM and PM
DRUGBrimonidine 0.33%
Applied to the face each AM 30 minutes after the application of Azelaic acid 15%
Sponsors
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Derm Research, PLLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| IGA | Week 4 | Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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. |
| 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 |
| 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 |
| VAS | Week 8 | participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable |
| 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) |
| Lesion Count | Week 4 | — |
| 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 |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % 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% | 10 |
| Brimonidine 0.33% Gel Brimonidine 0.33% Gel applied to the face each morning
Brimonidine 0.33% | 12 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Brimonidine 0.33% Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 11 Participants | 17 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 10 | 4 / 12 |
| serious Total, serious adverse events | 0 / 10 | 0 / 12 |
Outcome results
Primary
IGA
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | IGA | 1.8 units on a scale | Standard Deviation 0.9 |
| Brimonidine 0.33% Gel | IGA | 1.8 units on a scale | Standard Deviation 0.8 |
Primary
IGA
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | IGA | 1.6 units on a scale | Standard Deviation 1.2 |
| Brimonidine 0.33% Gel | IGA | 1.8 units on a scale | Standard Deviation 0.9 |
Primary
IGA
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | IGA | 1.3 units on a scale | Standard Deviation 1.1 |
| Brimonidine 0.33% Gel | IGA | 1.4 units on a scale | Standard Deviation 0.9 |
Primary
Investigator Global Assessment (IGA) at Baseline
Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Time frame: Baseline
Population: Only participants who were not lost to follow up or did not withdraw consent were included in the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Investigator Global Assessment (IGA) at Baseline | 3 units on a scale | Standard Deviation 0 |
| Brimonidine 0.33% Gel | Investigator Global Assessment (IGA) at Baseline | 3.1 units on a scale | Standard Deviation 0.3 |
Secondary
Clinician's Erythema Assessment
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Clinician's Erythema Assessment | 2.3 units on a scale | Standard Deviation 0.5 |
| Brimonidine 0.33% Gel | Clinician's Erythema Assessment | 2.1 units on a scale | Standard Deviation 0.3 |
Secondary
Dermatology Life Quality Index (DLQI)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Dermatology Life Quality Index (DLQI) | 1.8 units on a scale | Standard Deviation 1.5 |
| Brimonidine 0.33% Gel | Dermatology Life Quality Index (DLQI) | 2.6 units on a scale | Standard Deviation 2 |
Secondary
Dermatology Life Quality Index (DLQI)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Dermatology Life Quality Index (DLQI) | 2.6 units on a scale | Standard Deviation 3.7 |
| Brimonidine 0.33% Gel | Dermatology Life Quality Index (DLQI) | 2.9 units on a scale | Standard Deviation 1.9 |
Secondary
DLQI
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | DLQI | 1.2 units on a scale | Standard Deviation 1.2 |
| Brimonidine 0.33% Gel | DLQI | 2.8 units on a scale | Standard Deviation 2.8 |
Secondary
DLQI
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | DLQI | 1.3 units on a scale | Standard Deviation 1.2 |
| Brimonidine 0.33% Gel | DLQI | 2.6 units on a scale | Standard Deviation 2.6 |
Secondary
Erythema
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Erythema | 1.6 units on a scale | Standard Deviation 0.7 |
| Brimonidine 0.33% Gel | Erythema | 1.3 units on a scale | Standard Deviation 0.7 |
Secondary
Erythema
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Erythema | 1.3 units on a scale | Standard Deviation 0.8 |
| Brimonidine 0.33% Gel | Erythema | 1.4 units on a scale | Standard Deviation 0.7 |
Secondary
Erythema
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Erythema | 1.3 units on a scale | Standard Deviation 0.7 |
| Brimonidine 0.33% Gel | Erythema | 1.2 units on a scale | Standard Deviation 0.8 |
Secondary
Erythema Visual Analog Scale (VAS) Assessment (Subject)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Erythema Visual Analog Scale (VAS) Assessment (Subject) | 5.5 units on a scale | Standard Deviation 2.5 |
| Brimonidine 0.33% Gel | Erythema Visual Analog Scale (VAS) Assessment (Subject) | 5.6 units on a scale | Standard Deviation 1.8 |
Secondary
Lesion Count
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Lesion Count | 1.1 lesions | Standard Deviation 1.2 |
| Brimonidine 0.33% Gel | Lesion Count | 2.1 lesions | Standard Deviation 2.9 |
Secondary
Lesion Counts
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Lesion Counts | 1.0 lesions | Standard Deviation 1.4 |
| Brimonidine 0.33% Gel | Lesion Counts | 1.7 lesions | Standard Deviation 2.1 |
Secondary
Lesion Counts
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Lesion Counts | 0.7 lesions | Standard Deviation 1.3 |
| Brimonidine 0.33% Gel | Lesion Counts | 1.2 lesions | Standard Deviation 1.3 |
Secondary
Lesion Counts
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Lesion Counts | 3.3 lesions | Standard Deviation 1.6 |
| Brimonidine 0.33% Gel | Lesion Counts | 4.5 lesions | Standard Deviation 2.8 |
Secondary
VAS
participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | VAS | 4.4 units on a scale | Standard Deviation 3 |
| Brimonidine 0.33% Gel | VAS | 4.5 units on a scale | Standard Deviation 2.1 |
Secondary
VAS
participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | VAS | 3.8 units on a scale | Standard Deviation 2.3 |
| Brimonidine 0.33% Gel | VAS | 4.0 units on a scale | Standard Deviation 2.1 |
Secondary
Visual Analog Scale (VAS)
participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Visual Analog Scale (VAS) | 4.5 units on a scale | Standard Deviation 2.4 |
| Brimonidine 0.33% Gel | Visual Analog Scale (VAS) | 5.2 units on a scale | Standard Deviation 2.1 |