Clinical Evaluation of Hair Removal and Permanent Hair Reduction for Skin Types V-VI Using Intense Pulsed Light
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Hair Count 6 Months Following Last Treatment
研究概览
简要总结
This is a Multi-center, blinded, baseline-controlled, prospective study to evaluate permanent hair reduction and removal for skin types V and VI using IPL.
详细描述
One hundred and twenty (120) subjects who are Fitzpatrick Skin Type V-VI, and have a suitable treatment area for hair removal will be evaluated in this study.
Each subject will receive six treatments at four to six week intervals upon re-growth of hair and return for follow-up visits at one, three and six months after the last treatment.
Measurement Equipment Standard High Resolution Digital Camera
Labels for hair count Customized hair count sticker templates will be placed directly on the skin and the hairs in this window will be counted at specific visits during the study as detailed in section.
Study Procedures Each subject will participate in the study for a period of at least 11 months. The study is anticipated to be completed within twelve months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older 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;
- •Subject has black or dark brown terminal hairs in the areas to be treated.
- •Terminal hair density requirement of greater than 15 hairs within the hair count site (3x3 cm area) as determined by manual hair count performed by the study investigator.
- •Healthy adult, male or female, 21 years of age or older with skin type V-VI;
- •Having a suitable treatment area for hair removal;
- •Able and willing to comply with the treatment/follow-up schedule and requirements;
- •Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.
排除标准
- •Subject has light ,gray terminal or fine hairs in all/some parts of the treated area;
- •Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
- •Hormonal disorders that may affect hair growth;
- •Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
- •Livedo reticularis;
- •Uncontrolled systemic diseases such as diabetes;
- •Active infections in the treated area;
- •Dysplastic nevi;
- •Significant concurrent skin conditions or any inflammatory skin conditions;
- •Active cold sores, open lacerations or abrasions;
- •Chronic or cutaneous viral, fungal, or bacterial diseases;
- •Current cancer;
- •History of skin cancer or pre-cancerous lesions at the treatment areas;
- •Use of Accutane™ (Isotretinoin) within the past six month;
- •Keloid or Hypertrophic scar formation in the treatment area;
- •Tattoos in the treatment area;
- •Bleeding coagulopathies or use of anticoagulants;
- •Auto-immune disorders;
- •Erythema abigne, when identified treatments should be discontinued;
- •Photosensitivity disorder that can be exacerbated by laser or intense light;
- •Herpes simplex in the treatment area;
- •Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;
- •Poor wound healing;
- •Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a month) and during the course of the evaluation;
- •Prior skin treatment with laser or other devices on the same treated areas within the last six months prior to study enrollment or during the course of the study.
结局指标
主要结局
Hair Count 6 Months Following Last Treatment
时间窗: 6 months after last treatment
Hair count reduction in marked treatment area assessed from photographs taken 6 months following the last treatment as compared to photographs of the marked treatment area taken at baseline.
次要结局
未报告次要终点