NCT03944278已完成不适用
Pilot Evaluation of Thulium Laser Alone or in Combination With Broad Band Light for Treatment of Dermatologic Conditions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sciton
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Photography
研究概览
简要总结
Evaluate the Thulium laser device for skin resurfacing procedures, or as a treatment for pigmented lesions (age or sun spots) or dyschromia; or cutaneous lesions such as, but not limited to, actinic keratosis, melasma, fine rhytides; or as a method of improving skin tone and skin texture
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
- •Female or Male, 18 years and older
- •Fitzpatrick Skin Type I-VI
- •Subject has visible signs of moderate sun-damages and/or aging facial skin with visible areas of fine rhytides, pigmentation, and erythema or telangiectasia.
- •Desires non-ablative photo-revitalization of the skin.
- •Subject must agree to not make any changes in their skin regimen for the duration of the study, including the follow-up period.
- •Subject must be able to read, understand and sign the Informed Consent Form.
- •Must be willing and able to adhere to the treatment and follow-up schedule and post- treatment care instructions.
- •Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period.
- •Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
- •Agree to not undergo any other procedure(s) in the treatment area during the study, such as laser- or light-based treatment, non-light based device treatment such as radiofrequency or ultrasound, injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler, chemical peel, or surgical procedure
排除标准
- •Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- •Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser or light-based procedures or surgery.
- •Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler in the target area within 1 week of study participation.
- •History of malignant tumors in the target area.
- •Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
- •Pregnant and/or breastfeeding.
- •Having an infection, dermatitis or a rash in the treatment area.
- •Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
- •Suffering from coagulation disorders or taking prescription anticoagulation medications.
- •History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- •History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- •History of vitiligo, eczema, or psoriasis.
- •History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- •History of seizure disorders due to light.
- •Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- •History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
- •History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- •History of pigmentary disorders, particularly tendency for hyper- or hypo- pigmentation.
- •Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
- •Topical use of retinoid, such as isotretinoin, corticosteroid or hydroquinone on the target area within 1 month of participation.
- •Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- •Excessively tanned in areas to be treated, or unable/unlikely to refrain from tanning during the study (for example, subject's occupation requires regular sun exposure).
- •Current smoker or history of smoking within 6 months of study participation.
- •Has infectious disease
- •Has been on long-standing systemic steroids (e.g. Prednisone, Dexamethasone)
- •Has medical condition that may affect wound healing
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
结局指标
主要结局
Photography
时间窗: 6 weeks post final treatment
Change in photography when compared to baseline using Physicians global assessement scale
次要结局
- Pain scores(Immediately after each treatment received)
研究者
研究点 (2)
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