RecruitingNot ApplicableNCT07300917

1726-nm Diode Laser for Lip Fordyce Spots

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


Sponsor

Venus Research Center

Enrollment

20 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAccure 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.


Locations(1)

Hosn Clinics

Khobar, Eastern Province, Saudi Arabia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07300917