NCT02180282终止不适用
Impact of the M22-IPL Acne Filter on Acne Vulgaris
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- lesion count of acne vulgaris will be reduced by at least 50% for >75% of the study population.
研究概览
简要总结
Up to 20 healthy subjects age 15-45 years old ,Skin Phototype I-V,Study will be conducted in 1 site.
Primary objectives is to evaluate the efficacy of IPL acne filter treatment for improvement of acne vulgaris as assessed by lesion count.
.
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
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to read, understand and provide written Informed Consent;
- •Healthy male or female, 15-45 years of age;
- •Fitzpatrick skin type I-V;
- •Have at least 15 inflammatory lesions (papules and pustules) in the face.
- •Having clinical diagnosis of mild to moderate inflammatory acne on face with Investigator Global Acne scale = 2 and 3;
- •Able and willing to comply with the treatment/follow-up schedule and requirements;
- •Women of child-bearing age are required to be using a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, Nova ring, and partner with vasectomy or abstinence) at least 3 months prior to enrollment and throughout the course of the study.
排除标准
- •Skin type VI;
- •Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding;
- •Heavy smoker (>1 pack of cigarettes a day);
- •Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study;
- •Photosensitivity or any sensitivity to the sun that causes a rash or allergic reaction;
- •Use of photosensitive medication for which light exposure is contraindicated;
- •Treatment with topical retinoid therapy or antibiotics for the treatment of acne within 2 weeks of study enrollment or during the study.
- •Treatment with oral retinoid medications (Accutane® or Soriatane®) within 6 months of the study enrollment or during the study.
- •Treatment with any topical or systemic anti acne therapy for at least 2 weeks prior to starting the study treatment or during the study.
- •Any history of gold therapy;
- •Prior use of collagen, fat injections or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 12 months of initial treatment or during the course of the study. Treatment may not be performed at all over permanent dermal implants;
- •Prior ablative resurfacing procedure or face lift in treated area with laser or other devices within 12 months of initial treatment or during the course of the study;
- •Any other surgery in treated area within 9 months of initial treatment or during the course of the study;
- •Participation in a study of another investigational device or drug involving the same anatomical site within 3 month prior to enrollment or during this evaluation, or if not involving the same anatomical site, as per the Investigator's discretion;
- •History of keloid or any other type of hypertrophic scar formation or poor wound healing in a previously injured skin area;
- •Showing symptoms of hormonal disorders, as per the Investigator's discretion (such as Melasma, Chloasma);
- •Concurrent inflammatory skin conditions, Open laceration or abrasion of any sort on area to be treated during the course of treatment;
- •Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study enrollment;
- •Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion);
- •History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
- •Having any form of active cancer at the time of enrollment and during the course of the study or history of skin cancer on the face;
- •Mentally incompetent or evidence of active substance or alcohol abuse;
- •Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study;
- •For subjects undergoing test spots: considerable undesired response consisting of skin hypopigmentation (long term whitening), a scar or pre scar formation or any response deemed by the Investigator as grounds for exclusion.
结局指标
主要结局
lesion count of acne vulgaris will be reduced by at least 50% for >75% of the study population.
时间窗: week 6 (week 1 after the last treatment)
The numbers of lesions are counted on each side of the face according to lesion type
次要结局
- The Cardiff Acne Disability Index(Baseline ,4,6,10 weeks)
- Long term side effect and adverse events(throughout the duration of the study (Baseline,2,3,4,5 weeks))
- Subject Downtime Evaluation(Following treatments baseline,2,3,4,5 weeks)
- Investigator Global Assessment (IGA) Scale for Acne Vulgaris(following the treatments: at Baseline ,5 weeks and at follow up 6 and 10 weeks.)
- Subject Satisfaction(week 4 ,6 ,10)
- Subject Discomfort Evaluation(Following the treatments: Baseline,2,3,4,5 weeks)
- Subject personal experience(week 10)
研究者
研究点 (2)
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