1726-nm Diode Laser for Lip Fordyce Spots

Venus Research Center

Status: Enrolling

Conditions: Fordyce Spots

Treatments: Device: Accure 1726-nm Diode Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT07300917

Accure_Fordyce_Spots

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Accure 1726-nm Laser Treatment

Experimental group

Description:

Participants receive treatment to the entire affected lip and/or vermilion area using a 1726-nm sebaceous-targeting diode laser (Accure®) delivered in 2-3 sessions at four-week intervals.

Treatment:

Device: Accure 1726-nm Diode Laser