Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-11-01
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Accure 1726-nm Laser Treatment
Participants receive treatment to the entire affected lip and/or vermilion area using a 1726-nm sebaceous-targeting diode laser (Accure®) delivered in 2-3 sessions at four-week intervals.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Venus Research Center
OTHER
Responsible Party
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Mahmoud Rageh
Dermatologist
Locations
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Hosn Clinics
Khobar, Eastern Province, Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Mahmoud A. Rageh, MD, PhD
Role: primary
Other Identifiers
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Accure_Fordyce_Spots
Identifier Type: -
Identifier Source: org_study_id