Facial Papules in Frontal Fibrosing Alopecia (FFA)

Официальное название

Evaluating the Efficacy of the 1726nm Laser for the Treatment of Facial Papules in Frontal Fibrosing Alopecia (FFA)

Обзор

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).

Вмешательства

• Устройство Cutera® 1726 nm laser system
  Participants will receive 3 laser treatments at 4 (±1) week intervals and will be followed at approximately at 12 (± 2) weeks post treatment completion onsite.

Первичные конечные точки

• Change in lesion size (papule diameter in mm) measured by dermatoscope and ultrasound [Срок оценки: Baseline periprocedural and through study completion (an average of 30 weeks)]

Вторичные конечные точки (5)

• Change in lesion count measured by physical examination [Срок оценки: Baseline periprocedural and through study completion (an average of 30 weeks)]
• Change in lesion depth measured by optical coherence tomography (OCT) and/or ultrasound [Срок оценки: Baseline, periprocedural, and through study completion (an average of 30 weeks)]
• Change in appearance of facial papules assessed by standardized global photography [Срок оценки: Baseline, periprocedural and through study completion (an average of 30 weeks)]
• Change in Physician Global Assessment (PGA) score (9-point ordinal scale) [Срок оценки: Baseline and through study completion (an average of 30 weeks)]
• Blinded dermatologist evaluation [Срок оценки: After data collection is completed (an average of 30 weeks from baseline)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT07340671 · 20250543

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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