Fordyce Spots
Conditions
Keywords
Fordyce spots, Sebaceous glands, Lip lesions, Cosmetic dermatology, Diode laser, 1726 nm laser
Brief 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.
Detailed 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.
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.
Sponsors
Venus Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Reduction in Fordyce Spot Count | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Improvement Assessment (IGA) | Baseline to Week 12 | Change in investigator-rated global improvement using a 5-point scale ranging from no improvement to almost complete clearance. |
| Patient Global Aesthetic Improvement Scale (Patient-GAIS) | Baseline to Week 12 | Patient-reported global aesthetic improvement assessed using a 5-point scale ranging from no improvement to almost complete clearance. |
| Patient Satisfaction Score | Week 12 | Patient satisfaction with cosmetic outcome assessed using a visual analog scale from 0 (not satisfied) to 10 (extremely satisfied). |
| Treatment Safety and Tolerability | Baseline to Month 6 | Incidence and severity of treatment-related adverse events including pain, erythema, edema, mucosal erosion, ulceration, pigmentary changes, and herpes labialis reactivation. |
Countries
Saudi Arabia
Contacts
Primary ContactMahmoud A. Rageh, MD, PhD
Outcome results
None listed