1726-nm Diode Laser for Lip Fordyce Spots

Официальное название

Efficacy and Safety of a 1726-nm Sebaceous-Targeting Diode Laser for the Treatment of Fordyce Spots of the Lips: A Prospective Pilot Study

Обзор

Fordyce spots are benign ectopic sebaceous glands commonly affecting the lips and vermilion border, often causing cosmetic concern. This prospective pilot study evaluates the efficacy and safety of a 1726-nm sebaceous-targeting diode laser (Accure®) for the cosmetic treatment of Fordyce spots of the lips. Participants will receive 2-3 laser sessions and will be followed for 6-12 months to assess clinical improvement, patient satisfaction, and safety outcomes.

Подробное описание

This is a prospective, single-arm pilot study evaluating the use of a 1726-nm diode laser that selectively targets sebaceous glands via lipid absorption. The device employs a temperature-guided, multi-pulse delivery system with continuous cooling and is FDA-cleared for the treatment of inflammatory acne.

Eligible participants with clinically evident Fordyce spots of the lips and/or vermilion border will receive 2-3 treatment sessions spaced four weeks apart. Outcomes include lesion count reduction, global aesthetic improvement scores, patient satisfaction, and safety assessments. Follow-up visits will occur at Weeks 4, 8, 12, 24. To better characterize durability and recurrence, participants will be invited (optional) to return for an additional observational follow-up at Month 12 (±4 weeks), without any additional study treatment. Participants who do not attend the Month-12 visit will be considered complete after the Week-24 assessment and will not be contacted further beyond routine clinical care. All analyses of efficacy and safety will be based on assessments through Week 24, with Month-12 data summarized descriptively as extended follow-up where available.

Вмешательства

• Устройство Accure 1726-nm Diode Laser
  A 1726-nm sebaceous-targeting diode laser (Accure®) delivering multi-pulse, temperature-guided energy with continuous cooling, applied to the lips and vermilion border in 2-3 treatment sessions spaced four weeks apart.

Первичные конечные точки

• Percentage Reduction in Fordyce Spot Count [Срок оценки: Baseline to Week 12]

Вторичные конечные точки (4)

• Investigator Global Improvement Assessment (IGA) [Срок оценки: Baseline to Week 12]
• Patient Global Aesthetic Improvement Scale (Patient-GAIS) [Срок оценки: Baseline to Week 12]
• Patient Satisfaction Score [Срок оценки: Week 12]
• Treatment Safety and Tolerability [Срок оценки: Baseline to Month 6]

Критерии участия

Критерии включения

• Age ≥18 years
• Clinically evident Fordyce spots involving: Upper and/or lower lips and/or vermilion border
• Cosmetic concern related to Fordyce spots
• Willingness to comply with study procedures and follow-up visits
• Ability to provide written informed consent

Критерии исключения

• Active herpes labialis at the treatment site
• History of frequent HSV reactivation without willingness for antiviral prophylaxis
• Isotretinoin use within the preceding 6 months
• Active inflammatory or infectious lip/mucosal disease (e.g., lichen planus, cheilitis, candidiasis)
• Known tendency for keloid or hypertrophic scarring Pregnancy or lactation
• Immunosuppression or uncontrolled systemic illness
• Previous treatment of Fordyce spots in the target area within 3 months

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

Саудовская Аравия · 1 центр

• Hosn Clinics — Khobar

Идентификаторы

NCT: NCT07300917 · Accure_Fordyce_Spots

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗