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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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This is a single center, open-label, split-face, prospective study of ten to fifteen subjects seeking vascular laser therapy for the treatment of mild to moderate rosacea. Subjects will be screened for eligibility for vascular laser therapy outside of the confines of this protocol. Once approved for laser, subjects will be screened for study enrollment and topical treatment of their rosacea at the Screening/Baseline visit. All subjects will receive Finacea 15% gel and will be instructed to apply the study drug to one half of the face, twice daily. Drug application will be modified just prior to and after the subjects' laser treatment to reduce irritation. Subjects will undergo Vascular Nd:Yag laser therapy to involved areas over the whole face two weeks after initiating Finacea treatment. Subjects will continue to use Finacea gel to one half of the face for the duration of the study.
This is a single center, open-label, split-face, prospective study of ten to fifteen subjects seeking vascular laser therapy for the treatment of mild to moderate rosacea. Subjects will be screened for eligibility for vascular laser therapy outside of the confines of this protocol. Once approved for laser, subjects will be screened for study enrollment and topical treatment of their rosacea at the Screening/Baseline visit. All subjects will receive Finacea 15% gel and will be instructed to apply the study drug to one half of the face, twice daily. Drug application will be modified just prior to and after the subjects' laser treatment to reduce irritation. Subjects will undergo Vascular Nd:Yag laser therapy to involved areas over the whole face two weeks after initiating Finacea treatment. Subjects will continue to use Finacea gel to one half of the face for the duration of the study. Assessment of acneiform lesions, redness, and telangiectasias will be performed at Screening/Baseline, Week 2 (prior to laser treatment), and week 6/End of Study. Photography will be performed at Screening/Baseline and End of Study visits. Adverse events will be assessed at each visit, and a patient survey will be completed at Baseline and at Week 6/End of Study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azelaic Acid plus Laser | Experimental | Azelaic acid 15% twice daily on half the face for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks. |
|
| Laser only | Active Comparator | laser treatment on all face once at 2 weeks with no azelaic acid on one side of the face |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelaic acid | Drug | 15% gel on half the face, twice daily, 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| IGA of Improvement | Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from 0 = Clear or "No inflammatory signs of rosacea" to 6 = "Severe inflammatory signs of rosacea." | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy McMichael, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences Dept of Dermatology | Winston-Salem | North Carolina | 27104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azelaic Acid Left Side Plus Laser | Azelaic acid 15% twice daily for 6 weeks to the left side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks. Azelaic acid: 15% gel, twice daily, 6 weeks Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2. |
| FG001 | Azelaic Acid Right Side Plus Laser | Azelaic acid 15% twice daily for 6 weeks to the right side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks. Azelaic acid: 15% gel, twice daily, 6 weeks Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azelaic Acid Left Side Plus Laser | Azelaic acid 15% twice daily for 6 weeks to the left side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks. Azelaic acid: 15% gel, twice daily, 6 weeks Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | IGA of Improvement | Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from 0 = Clear or "No inflammatory signs of rosacea" to 6 = "Severe inflammatory signs of rosacea." | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azelaic Acid Plus Laser | Azelaic acid 15% twice daily for 6 weeks on one side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| herniated disc | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Amy McMichael | WakeForest University Health Sciences | 336-716-3775 | amcmicha@wakehealth.edu |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C010038 | azelaic acid |
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| Nd:Yag laser | Device | Treatment with Nd:Yag laser , once at Week 2. |
|
| Azelaic Acid Right Side Plus Laser |
Azelaic acid 15% twice daily for 6 weeks to the right side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks. Azelaic acid: 15% gel, twice daily, 6 weeks Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Laser treatment with no azelaic acid on one side of face
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Laser Only | Laser treatment with no azelaic acid on one side of face | 0 | 10 | 0 | 10 | 0 | 10 |
| Burning | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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