Back to resultsCombination Gel and Vascular ND in Mild to Moderate Rosacea
Primary Purpose
Rosacea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Azelaic acid
Nd:Yag laser
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea focused on measuring Rosacea, Laser, Finacea Gel, Azelaic Acid,
Eligibility Criteria
Inclusion Criteria:
- Male or female subject with mild to moderate rosacea, age 18 and over, who agrees to participate and provide written consent.
- Have an Investigator Global Assessment of mild to moderate rosacea (IGA rating between 2 and 5 in the Investigator Global Assessment (Appendix B) and at least a "Mild" rating on the Telangiectasia Rating Scale
- Subjects must be eligible to undergo vascular laser therapy and have been previously approved for therapy.
Exclusion Criteria:
- Initiation or change in dose within 4 weeks of baseline of systemic anti-inflammatory medication which may influence study outcome.
- Use of topical therapy for rosacea within 2 weeks of baseline.
- Use of systemic corticosteroids within 4 weeks of baseline.
- Use of systemic retinoids within 6 months of baseline
- Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
- Amount of disease involvement that would require >60 gm of cream in a 6 week period.
- Subjects with known allergy or sensitivity to azelaic acid (Finacea®) gel or components therein, such as propylene glycol.
- Contraindication to vascular laser therapy, such as infections.
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
Sites / Locations
- Wake Forest University Health Sciences Dept of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Azelaic Acid plus Laser
Laser only
Arm Description
Azelaic acid 15% twice daily on half the face for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks.
laser treatment on all face once at 2 weeks with no azelaic acid on one side of the face
Outcomes
Primary Outcome Measures
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."
Secondary Outcome Measures
Full Information
NCT ID
NCT01631656
First Posted
June 27, 2012
Last Updated
August 13, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT01631656
Brief Title
Combination Gel and Vascular ND in Mild to Moderate Rosacea
Official Title
Combination Finacea Gel and Vascular Nd:Yag Laser Therapy for Mild to Moderate Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
Rosacea, Laser, Finacea Gel, Azelaic Acid,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azelaic Acid plus Laser
Arm Type
Experimental
Arm Description
Azelaic acid 15% twice daily on half the face for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks.
Arm Title
Laser only
Arm Type
Active Comparator
Arm Description
laser treatment on all face once at 2 weeks with no azelaic acid on one side of the face
Intervention Type
Drug
Intervention Name(s)
Azelaic acid
Other Intervention Name(s)
Finacea gel
Intervention Description
15% gel on half the face, twice daily, 6 weeks
Intervention Type
Device
Intervention Name(s)
Nd:Yag laser
Intervention Description
Treatment with Nd:Yag laser , once at Week 2.
Primary Outcome Measure Information:
Title
IGA of Improvement
Description
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."
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subject with mild to moderate rosacea, age 18 and over, who agrees to participate and provide written consent.
Have an Investigator Global Assessment of mild to moderate rosacea (IGA rating between 2 and 5 in the Investigator Global Assessment (Appendix B) and at least a "Mild" rating on the Telangiectasia Rating Scale
Subjects must be eligible to undergo vascular laser therapy and have been previously approved for therapy.
Exclusion Criteria:
Initiation or change in dose within 4 weeks of baseline of systemic anti-inflammatory medication which may influence study outcome.
Use of topical therapy for rosacea within 2 weeks of baseline.
Use of systemic corticosteroids within 4 weeks of baseline.
Use of systemic retinoids within 6 months of baseline
Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
Amount of disease involvement that would require >60 gm of cream in a 6 week period.
Subjects with known allergy or sensitivity to azelaic acid (Finacea®) gel or components therein, such as propylene glycol.
Contraindication to vascular laser therapy, such as infections.
Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy McMichael, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Dept of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combination Gel and Vascular ND in Mild to Moderate Rosacea
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