1726-nm Diode Laser for Lip Fordyce Spots
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Accure 1726-nm Diode Laser.
- Who it may be relevant to
- Registry conditions: Fordyce Spots. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of a 1726-nm Sebaceous-Targeting Diode Laser for the Treatment of Fordyce Spots of the Lips: A Prospective Pilot Study
Overview
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
- Device Accure 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.
Primary outcome measures
- Percentage Reduction in Fordyce Spot Count [Time frame: Baseline to Week 12]
Secondary outcome measures (4)
- Investigator Global Improvement Assessment (IGA) [Time frame: Baseline to Week 12]
- Patient Global Aesthetic Improvement Scale (Patient-GAIS) [Time frame: Baseline to Week 12]
- Patient Satisfaction Score [Time frame: Week 12]
- Treatment Safety and Tolerability [Time frame: Baseline to Month 6]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Saudi Arabia · 1 center
- Hosn Clinics — Khobar
Identifiers
NCT: NCT07300917 · Accure_Fordyce_Spots