Pilot Study to Evaluate Vbeam® Prima Pulsed Dye Laser (PDL) Treatment and RHOFADE® (Oxymetazoline HCL, 1% Cream) for Erythematotelangiectatic Rosacea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Clinical Erythema Assessment (CEA) Score At 6-Month Post-Baseline
研究概览
简要总结
This study will compare treatment outcome with pulsed dye laser, when used used as an adjunctive treatment to oxymetazoline HCl 1% cream, compared to oxymetazoline HCL 1% cream alone, for patients with moderate or severe erythematotelangiectatic rosacea.
详细描述
This is a prospective, two-arm randomized, baseline-controlled, pilot study to evaluate treatment outcome of 3 Vbeam® Prima PDL treatments in subjects applying once-daily RHOFADE® topical oxymetazoline HCL 1.0% cream for improvement in erythematotelangiectatic rosacea. Treatment outcome will be compared to oxymetazoline HCL 1% cream alone.
Subjects with moderate or severe (Grade 3 or 4) erythematotelangiectatic rosacea on the validated Clinical Erythema Assessment (CEA) Scale and Subject Self-Assessment (SSA) Scale will be enrolled and randomized to one of two study arms:
Arm 1- 3 monthly treatments with Vbeam® PDL with daily RHOFADE® topical oxymetazoline HCL 1.0% cream.
Arm 2 -Treatment with daily RHOFADE® topical oxymetazoline HCL 1.0% cream only.
All subjects will apply RHOFADE® cream daily during the 6-month study. After 1-month of RHOFADE® cream, subjects in the combined treatment Arm 1 will receive the first of three monthly Vbeam® PDL treatments (at 4-week intervals) with a 3-day washout of cream before each treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a healthy male or female of 18 to 75 years of age.
- •Subject has erythematotelangiectatic rosacea with clinician erythema assessment (CEA) and subject self-assessment (SSA) of "moderate" or "severe" (Grade 3 or 4).
- •Fitzpatrick Skin Type I - VI.
- •Subject must be able to read, understand and sign the Informed Consent Form.
- •Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- •Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period up to 6 months post-baseline.
- •Subject is willing to have photographs taken of the treated area that will be used, de-identified, in evaluations and may be used, de-identified, in presentations and/or publications.
- •For female candidates - subject must be post-menopausal, or surgically sterilized, or using a medically acceptable form of birth control during the entire course of the study.
排除标准
- •Subject is pregnant or planning to become pregnant during the study duration.
- •Subject has an active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- •Subject has an implant in the treated area (such as metal plates or screws) or an injected chemical substance.
- •Subject has a known collagen (connective tissue) disorder, vascular disease, scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
- •Subject has a history of diseases stimulated by heat or sun exposure, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- •Subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- •Having or undergoing any form of treatment for active cancer or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
- •Subject is suffering from significant concurrent illness, such as such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
- •Subject has an infection or is suffering from current or has a history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: photodermatoses, active acne, excessive skin dryness, psoriasis, eczema, rash, open wounds, varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- •Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use might be requested as per the subject's physician discretion).
- •Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
- •Subject has a history of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- •Subject has a history of keloid scarring or of abnormal wound healing.
- •Subject has a known photosensitivity to the device's laser wavelengths, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
- •Subject has undergone any surgical, light-based therapy or radiofrequency (RF) procedures in the treatment area within 3 months of treatment or during the study.
- •Having undergone any other surgery in the treated area within 3 months of treatment (or more if skin has not healed completely) or during the study.
- •Subject has a tattoo or permanent make-up in the treated area.
- •Subject has systemically used retinoids or antioxidants within 1 month of treatment or during the study.
- •Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- •Participation in a study of another device or drug within three months prior to enrollment or during the study.
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
研究组 & 干预措施
Pulsed Dye Laser & Oxymetazoline HCL 1% Cream
Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments.
干预措施: The Vbeam® Prima System (Device)
Pulsed Dye Laser & Oxymetazoline HCL 1% Cream
Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments.
干预措施: Oxymetazoline HCL 1% Cream (Drug)
Oxymetazoline HCL 1% Cream
Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study.
干预措施: Oxymetazoline HCL 1% Cream (Drug)
结局指标
主要结局
Clinical Erythema Assessment (CEA) Score At 6-Month Post-Baseline
时间窗: 6-month post-baseline
CEA was graded by the investigator according to 5-point scale (0=Clear to 4=Severe) for each patient at the 6-month post-baseline visits. A higher score indicates worse outcome. The outcomes presented here are the mean CEA calculated for the 6-month post-baseline visit of each arm.
次要结局
- Clinical Erythema Assessment (CEA) At the 1- ,2- and 3-Month Post-Baseline Visits(1- ,2- and 3-Month Post-Baseline Visits)
- Subject Self-Assessment (SSA) At the 1- ,2-, 3- and 6-Month Post-Baseline Visits(1-, 2-, 3- and 6-months post-baseline)
- Mean Investigator Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline(1-, 2-, 3- and 6-month post-baseline)
- Mean Subject Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline(1-, 2-, 3- and 6-month post-baseline)
- Measurement of Improvement in Vessel Size At the 1-, 2-, 3- and 6-Month Post-Baseline Visits(1-, 2-, 3- and 6-month post-baseline)
- Measurement of The Percentage of Subjects Reporting Satisfaction At the 6-Month Post-Baseline Visit(6-month post-baseline)
- Measurement of Pain Associated With PDL Treatment(1-, 2- and 3-month post-baseline)