Rosacea
Conditions
Keywords
Rosacea, Laser, Finacea Gel, Azelaic Acid,
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.
Interventions
DRUGAzelaic acid
15% gel on half the face, twice daily, 6 weeks
DEVICENd:Yag laser
Treatment with Nd:Yag laser , once at Week 2.
Sponsors
Bayer
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IGA of Improvement | 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Azelaic Acid Left Side Plus Laser | Azelaic Acid Right Side Plus Laser | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 4 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azelaic Acid Plus Laser | IGA of Improvement | 3.1 units on a scale | Standard Deviation 1.2 |
| LASER ONLY | IGA of Improvement | 3.5 units on a scale | Standard Deviation 1.4 |