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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Hosn Clinics
Khobar, Eastern Province, Saudi Arabia
RECRUITINGPercentage Reduction in Fordyce Spot Count
The percentage change from baseline in the number of visible Fordyce spots on the lips and vermilion border, assessed using standardized clinical photographs and lesion counting within predefined grid areas.
Time frame: Baseline to Week 12
Investigator Global Improvement Assessment (IGA)
Change in investigator-rated global improvement using a 5-point scale ranging from no improvement to almost complete clearance.
Time frame: Baseline to Week 12
Patient Global Aesthetic Improvement Scale (Patient-GAIS)
Patient-reported global aesthetic improvement assessed using a 5-point scale ranging from no improvement to almost complete clearance.
Time frame: Baseline to Week 12
Patient Satisfaction Score
Patient satisfaction with cosmetic outcome assessed using a visual analog scale from 0 (not satisfied) to 10 (extremely satisfied).
Time frame: Week 12
Treatment Safety and Tolerability
Incidence and severity of treatment-related adverse events including pain, erythema, edema, mucosal erosion, ulceration, pigmentary changes, and herpes labialis reactivation.
Time frame: Baseline to Month 6
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