NCT07340671招募中不适用
Evaluating the Efficacy of the 1726nm Laser for the Treatment of Facial Papules in Frontal Fibrosing Alopecia (FFA)
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in lesion size (papule diameter in mm) measured by dermatoscope and ultrasound
研究概览
简要总结
The objective is to evaluate the safety and efficacy of the Cutera 1726 nm laser system (also referred to as AviClear) for the treatment of facial papules in frontal fibrosing alopecia (FFA).
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
- 否
入选标准
- •Female or Male
- •Fitzpatrick Skin Types I-VI
- •At least 18 years of age
- •Has clinically diagnosed FFA with facial papules.
- •Subject must be able to read, speak, and understand English or Spanish and sign the Informed Consent Form.
- •Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
- •No contraindication to laser therapy.
- •Willing to have photographs taken of the treatment area and agree to the use of photographs for presentation, educational or marketing purposes.
- •Agree to not undergo any other procedure(s) or add any new treatment modalities in the treatment area during the study.
- •Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.
排除标准
- •Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation.
- •Prior treatment to the target area within 3 months of study participating including chemical peel, dermabrassion, microneedling, radiofrequency treatment, laser or light-based procedures, cryodestruction or chemodestruction, intralesional steroids, photodynamic therapy, or acne surgery.
- •Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study.
- •Systemic use of retinoid, such as isotretinoin, within 3 months of study participation.
- •Still healing from another treatment in the target area according to investigator's discretion.
- •History of malignant tumors in the target area.
- •Pregnant and/or breastfeeding or planning to become pregnant during the study.
- •History of diagnosed immunosuppression/immune deficiency or currently using immunosuppressive medications.
- •History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- •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 target area, unless treatment is conducted following a prophylactic regimen.
- •History of radiation to the target area, currently undergoing treatment for skin cancer in the target area, or undergoing systemic chemotherapy for the treatment of cancer.
- •History of diagnosed pigmentary disorders (including vitiligo) in the target area.
- •Excessively tanned in the treatment area or unable/unlikely to refrain from tanning in the target area during the study.
- •History of keloids or hypertrophic scarring.
- •Prisoners
- •As per the Investigator's discretion, any physical, mental or medical condition which might make it unsafe for the subject to participate in this study, might interfere with patient's participation in the full study protocol, or might interfere with the diagnosis or assessment of facial papules.
研究组 & 干预措施
1726 nm Laser Treatment Group
Experimental
Participants will be in this group for up to approximately 30 weeks and complete up to 5 visits
干预措施: Cutera® 1726 nm laser system (Device)
结局指标
主要结局
Change in lesion size (papule diameter in mm) measured by dermatoscope and ultrasound
时间窗: Baseline periprocedural and through study completion (an average of 30 weeks)
Lesion size will be assessed using dermatoscope and ultrasound imaging. Measurements will be recorded in millimeters (mm) and compared to baseline values to evaluate treatment response.
Change in lesion size (papule diameter in mm) measured by dermatoscope and ultrasound
时间窗: Baseline (Pretreatment), immediately after each treatment session, and at 12 week follow up
Lesion size will be assessed using dermatoscope and ultrasound imaging. Measurements will be recorded in millimeters (mm) and compared to baseline values to evaluate treatment response.
次要结局
- Change in lesion count measured by physical examination(Baseline periprocedural and through study completion (an average of 30 weeks))
- Change in lesion depth measured by optical coherence tomography (OCT) and/or ultrasound(Baseline, periprocedural, and through study completion (an average of 30 weeks))
- Change in appearance of facial papules assessed by standardized global photography(Baseline, periprocedural and through study completion (an average of 30 weeks))
- Change in Physician Global Assessment (PGA) score (9-point ordinal scale)(Baseline and through study completion (an average of 30 weeks))
- Blinded dermatologist evaluation(After data collection is completed (an average of 30 weeks from baseline))
- Change in lesion count measured by physical examination(Baseline (Pretreatment) immediately after each treatment, and at 12 week follow up)
- Change in lesion depth measured by optical coherence tomography (OCT) and/or ultrasound(Baseline (Pretreatment) immediately after each treatment, and at 12 week follow up)
- Change in appearance of facial papules assessed by standardized global photography(Baseline (Pretreatment), immediately after each treatment, and at 12 week follow up)
- Change in Physician Global Assessment (PGA) score (9-point ordinal scale)(Baseline (Pretreatment) and 12 week follow up)
- Blinded dermatologist evaluation(Up to 30 weeks)
- Patient's self-assessment (PSA) scale(At baseline and through the completion of the study, approximate time of 30 weeks)
研究者
Ariel Eva Eber
Assistant Professor of Clinical
University of Miami
研究点 (1)
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