1726-nm Diode Laser for Lip Fordyce Spots

NCT07300917 | Recruiting FDA Device

• 1 other identifier: Accure_Fordyce_Spots
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fordyce Spots

Keywords

Fordyce spots; Sebaceous glands; Lip lesions; Cosmetic dermatology; Diode laser; 1726 nm laser

Outcome Measures

Primary Outcomes (1)

• Percentage 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.

  Baseline to Week 12

Secondary Outcomes (4)

• Investigator Global Improvement Assessment (IGA)

  Baseline to Week 12

• Patient Global Aesthetic Improvement Scale (Patient-GAIS)

  Baseline to Week 12

• Patient Satisfaction Score

  Week 12

• Treatment Safety and Tolerability

  Baseline to Month 6

Study Arms (1)

Accure 1726-nm Laser Treatment

EXPERIMENTAL

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.

Device: Accure 1726-nm Diode Laser

Interventions

Accure 1726-nm Diode Laser DEVICE

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.

Accure 1726-nm Laser Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Venus Research Center: lead

Study Sites (1)

Hosn Clinics

Khobar, Eastern Province, 31932, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Mahmoud A. Rageh, MD, PhD

CONTACT

+966535242572; dr.mahmoudrageh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: December 24, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months after publication and available for 5 years.
• Access Criteria: Data will be shared upon reasonable request to the corresponding author, following approval of a methodologically sound proposal and execution of a data use agreement.

Locations

SA (1)