Combination Finacea Gel and Vascular Nd:Yag Laser Therapy for Mild to Moderate Rosacea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- IGA of Improvement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Azelaic Acid plus Laser
Azelaic acid 15% twice daily on half the face for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks.
干预措施: Azelaic acid (Drug)
结局指标
主要结局
IGA of Improvement
时间窗: 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."
次要结局
未报告次要终点