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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

De-identified individual participant data, including baseline characteristics, lesion counts, and outcome measures, will be shared.

Beginning 6 months after publication and available for 5 years.

Data will be shared upon reasonable request to the corresponding author, following approval of a methodologically sound proposal and execution of a data use agreement.