1726-nm diode laser treatment for Fordyce spots on the lips
Efficacy and Safety of a 1726-nm Sebaceous-Targeting Diode Laser for the Treatment of Fordyce Spots of the Lips: A Prospective Pilot Study
This project will try a 1726-nm diode laser on adults with lip Fordyce spots to see if 2–3 treatments reduce their appearance and are safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Venus Research Center Academic / other |
| Locations | 1 site (Khobar, Eastern Province) |
| Trial ID | NCT07300917 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm pilot using a 1726-nm diode laser that selectively targets sebaceous glands through lipid absorption with temperature-guided, multi-pulse delivery and continuous cooling. Eligible adults with clinically evident Fordyce spots on the upper or lower lips or vermilion border will receive 2–3 treatment sessions spaced about four weeks apart. Outcomes through Week 24 include lesion count reduction, global aesthetic improvement scores, patient satisfaction, and safety monitoring, with an optional observational visit at Month 12 to characterize durability. The device is FDA-cleared for inflammatory acne, and this study applies the same sebaceous-targeting approach to cosmetic lip lesions.
Who should consider this trial
Good fit: Adults aged 18 or older with clinically evident Fordyce spots on the upper or lower lips or vermilion border who are bothered by their appearance and can attend follow-up visits are ideal candidates.
Not a fit: People with active herpes labialis at the treatment site, recent isotretinoin use, active inflammatory or infectious lip disease, pregnancy or lactation, immunosuppression, a tendency for keloid scarring, or prior treatment in the target area within 3 months may be excluded or less likely to benefit.
Why it matters
Potential benefit: If successful, the treatment could reduce the number and visibility of lip Fordyce spots, improving cosmetic appearance and patient satisfaction.
How similar studies have performed: Devices with sebaceous-targeting lasers have been used successfully for acne treatment, but applying a 1726-nm diode specifically to lip Fordyce spots is a novel, pilot application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Khobar, Eastern Province
- Hosn Clinics — Khobar, Eastern Province, Saudi Arabia (Recruiting)
Study contacts
- Study coordinator: Mahmoud A. Rageh, MD, PhD
- Email: dr.mahmoudrageh@gmail.com
- Phone: +966535242572
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.