NCT07214272进行中（未招募）不适用
A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing Procedures Using the Next Generation Fraxel® FTX Laser System in Participants With Dyschromia, Cutaneous Lesions, and Periorbital Rhytids
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 49
- 试验地点
- 10
- 主要终点
- Primary Endpoint
研究概览
简要总结
This study is a prospective, post-marketing (Phase 4) non-registrational single-arm, open-label, multicenter study.
详细描述
Study to be conducted at approximately 6 investigative sites in the United States, enrolling up to 50 male and female participants with Fitzpatrick skin types I to VI, with no more 30 (60%) participants with Fitzpatrick skin types I to III and approximately 20 (40%) participants who self-identify as being of Asian descent
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female.
- •21 to 60 years of age.
- •Written informed consent must be obtained prior to any study procedures.
- •Presence of one or more of the following in the treatment area(s):
- •Photodamage as determined by investigator using a Modified Griffith's Scale (score of 3 to 7 in overall photodamage on the 9-point scale)
- •Mild-to-moderate rhytids (e.g., periorbital crow's feet) as determined by investigator using a Modified Griffith's Scale (score of 3 to 6 on the 9-point scale).
- •Mild-to-severe dyschromia, including lentigos or solar lentigines as determined by investigator using the Modified Griffith's Scale (score of 3 to 9 on the 9-point scale).
- •Ability to read, understand, and sign the informed consent form
排除标准
- •Pregnant, breastfeeding, or planning to become pregnant during the study.
- •History of any type of allergic reaction to topical anesthetics.
- •Localized infection in the treatment area or systemic infection within the last 1 month prior to or at any time during the study.
- •Presence of melasma, rosacea, significant actinic keratoses, or other significant skin conditions in the target treatment zone.
- •Presence of skin cancer, infection, cold sore, open wounds, burns, psoriasis, or active dermatitis of any kind (atopic, contact, significant seborrheic dermatitis) in the target treatment zone.
- •Presence of skin conditions that, in the judgement of the investigator, would increase the risk of study participation or treatment.
- •Predisposition to keloid formation or excessive scarring.
- •Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, and/or scleroderma.
- •Known sensitivity to light or photosensitizing agents/medications are being taken that the investigator determines may affect study treatment.
- •Use of systemic steroids (e.g. prednisone, dexamethasone) or other immunosuppressants within 1 month prior to enrollment to or at any time during the study.
- •Use of topical retinoids within 2 weeks prior to enrollment or at any time during the study.
- •Use of systemic retinoids within 6 months prior to enrollment or at any time during the study.
- •Had a cosmetic procedure, such as a chemical peel, mechanical peel, laser resurfacing, and/or skin tightening procedures (microneedling, ultrasound, etc.) within the previous 4 months prior to enrollment.
- •Receiving short-acting botulinum toxin within 4 months or long-acting botulinum toxin administered to the targeted treatment zone within 9 months prior to enrollment or at any time during the study.
- •Receiving dermal fillers administered to the targeted treatment zone within 3 months prior to enrollment or at any time during the study.
- •Sunburn and/or significant recent sun exposure on the target treatment zone in the last 2 weeks prior to enrollment that, according to investigator judgement, would impact treatment, and/or unwilling to practice photoprotection and/or avoid significant sun exposure for the duration of study participation.
研究组 & 干预措施
Treatment Arm
Experimental
干预措施: Fraxel® FTX Laser System (Device)
结局指标
主要结局
Primary Endpoint
时间窗: 26 weeks
Proportion of participants with any improvement after 3 treatments as assessed by Investigator Global Aesthetic Improvement Scale (iGAIS) at End of Study
次要结局
- Secondary Endpoint(26 weeks)
研究者
研究点 (10)
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