NCT03284333已完成不适用
Open-label, Prospective, Multicenter Study to Evaluate the Cutera enLighten™ Laser and a Micro-Lens Array Handpiece Attachment for the Treatment of Moderate and Severe Acne Scars
Cutera Inc.3 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年7月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.
研究概览
简要总结
The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of acne scars.
详细描述
This is an open-label, prospective, multicenter, pivotal study in up to 45 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of acne scars. Subjects will receive up to 6 laser treatments, spaced 6 weeks (± 2 weeks) apart with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will be contacted by phone 7 days (± 2 days) after their first treatment for follow-up. Subjects will return to the site after all study treatments have been delivered for two follow-up visits: 6 and 12 weeks (± 2 weeks) following their final study treatment.
- The Primary Efficacy Endpoint as the correct identification of the 12 weeks post final treatment photographs from the baseline by at least two of the three blinded reviewers in 75% of the patients and an improvement of one point in the ASAS.
- The Secondary Efficacy Endpoints as the:
- Efficacy of the Cutera enlighten laser with the Micro-Lens Array handpiece attachment treatment as assessed by the investigator starting from the 2nd treatment onward, and
- Subject satisfaction levels as assessed from the subject questionnaire completed at the final follow-up visit 12 weeks post final treatment.
- The Safety Endpoint as the safety of the Cutera enlighten laser with Micro-Lens Array handpiece attachment as assessed by the frequency and severity of device related adverse events,
- The Exploratory Analysis as the Efficacy of the Cutera enlighten laser with a Micro-Lens Array handpiece attachment for the improvement of skin quality as assessed by the investigator and/or blinded evaluators 12-weeks-post final study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be able to read, understand and sign the Informed Consent Form.
- •Female or Male, 18 to 65 years of age (inclusive).
- •Fitzpatrick Skin Type I - VI (Appendix 6).
- •Subject desires treatment for acne scars and wishes to undergo laser treatments for improvement.
- •Subject has bilateral moderate to severe signs of facial acne scarring.
- •Must be willing to have Cutera enlighten laser with the Micro-Lens Array handpiece attachment treatments and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions.
- •Willing to have very limited sun exposure and use sunscreen 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 and/or marketing), publications, and any additional marketing purposes.
- •Agree to not undergo any other procedure(s) or treatment(s) for acne scars during the study and has no intention of having such procedures performed during the course of the study.
- •For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.,
排除标准
- •Participation in a clinical trial of another drug, or device administered to the treatment area, within 6 months prior to enrollment or during the study.
- •Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser procedures, facial fillers, i.e. (Bellafill) and those used for general aesthetic correction, facial peel, lightening creams, or facial surgery.
- •Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity.
- •Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
- •Pregnant and/or breastfeeding, or planning to become pregnant.
- •Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.
- •Hypersensitivity to light exposure.
- •Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.
- •History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.
- •Has a history of squamous cell carcinoma or melanoma in the treatment area.
- •History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
- •A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment.
- •History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- •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 pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation, or any that are considered not acceptable by the study investigator.
- •Has used oral isotretinoin (Accutane or therapeutic vitamin A supplements of ≥ 10,000 units per day) within 12 months of initial treatment or plans on using during the course of the study (note: skin must regain its normal degree of moisture prior to treatment, e.g. lack of noticeable skin flaking and peeling).
- •Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to refrain from tanning during the study.
- •Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment.
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.
结局指标
主要结局
Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.
时间窗: 12 weeks post-final treatment
visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)
次要结局
未报告次要终点
研究者
研究点 (3)
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