Post Market Clinical Study of an Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 5
- 主要终点
- Efficacity for Excessive Hairiness:
研究概览
简要总结
The first IPL device obtained United States Food and Drug Administration (FDA) clearance in 1995 for treatment of lower extremity telangiectasias. Since then, its favorable cost and versatility in contrast to many singlespectrum lasers, has led to its rapid proliferation and use in a number of different clinical settings. As described in the literature, ANTHÉLIA medical device is intended to treat skin disorders:
- Excessive Hairiness (Hirsutism, Hypertrichosis...)
- Vascular lesions (Rosacea....)
- Pigmented lesions (Lentigo et melasma)
- Acne vulgaris
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men or women
- •Excessive Hairiness:
- •Patient with unwanted hair on the body (legs, arms, bikini line, or axilla)
- •Patient over 18 years.
- •Patients with Fitzpatrick skin types from I to V.
- •Women were required to be post-menopausal, surgically sterilized, or under a medically acceptable form of birth control (i.e., oral contraceptives, IUD, contraceptive implant, or barrier methods with spermicide or abstinence) during the study time period.
- •Vascular lesions:
- •Patients over 18 years.
- •Patients with Fitzpatrick skin types from I to IV.
- •Patients with varicosities and Rosacea on the face or upper and lower limbs.
- •Pigmented lesions:
- •Patients over 18 years.
- •Patients with solar lentigines on their cheeks, back, hands, arm and leg (> 3 mm).
- •Patient with Fitzpatrick skin type from I to IV.
- •Patients over 18 years
- •Patients with Fitzpatrick skin types from I to IV.
- •Patients with facial acne vulgaris on face.
- •Willing to sun protect treated area for the duration of enrollment in the study and 4 weeks after treatment.
排除标准
- •Patients with history of malignant lesions or pre-malignant lesions, scarring, or infection in the area to be treated History of keloidal or hypertrophic scarring
- •Patients with a known photosensitivity
- •Pregnancy women
- •Patient with diabetes mellitus suntan in the area to be treated
- •Use of photo-sensitizing products for 7 days before treatment (selftanning lotions, activators, self-tanning shower gel, etc.)
- •Exposure to the sun or UV rays at least 4 weeks before the treatment and 1 week afterwards
- •Zones with uncovered tattoos, suspect spots or skin diseases (including spots, inflammation, beauty spots, tumors or melanomas, psoriasis, herpes...)
- •Use of medication that induces anticoagulative medication or thromboembolic condition
- •Patients with pacemaker or internal defibrillator
- •Patients that used of NSAIDS two weeks prior to or 2 weeks following the treatment
- •Epileptic patients
- •Additional criteria for excessive hair: Patients that use waxing or other methods of photo epilation within 1 month prior to treatment.
- •Additional criteria for acne: Patients currently under oral antibiotic or oral therapy for acne.
结局指标
主要结局
Efficacity for Excessive Hairiness:
时间窗: up to 18 months
Excessive Hairiness by hair counting a 4cm2 surface (To demonstrate a hair reduction of 50% between the average score of the treated aera before and after a cycle of treatment defined as six sessions spaced by 12 weeks)
Efficacity for Vascular lesions and Pigmented lesions
时间窗: up to 4 months
Vascular lesions: To demonstrate a reduction of 70% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 4 weeks. To demonstrate a clinical improvement of 50% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 4 weeks. Pigmented Lesions: To demonstrate a reduction of 60% between the average score of the treated aera before and after a cycle of treatment defined as three sessions spaced by 10 weeks.
Efficacity for Acne vulgaris
时间窗: up to 4 months
measuring the diameter of each pimple in a treated area (before and after), To demonstrate a lesion reduction of 50% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 2 weeks.
次要结局
- For all patients decrease of the IRBMS score(4 to 18 months)
- - For all patients decrease of the DLQI score(4 to 18 months)
- For only Acne patients, at least 20% reduction in the ECLA score(4 to 18 months)