1726-nm Diode Laser for Lip Fordyce Spots

Efficacy and Safety of a 1726-nm Sebaceous-Targeting Diode Laser for the Treatment of Fordyce Spots of the Lips: A Prospective Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Fordyce Spots
• Intervention / Treatment: Device: Accure 1726-nm Diode Laser

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud A. Rageh, MD, PhD; Phone Number: +966535242572; Email: dr.mahmoudrageh@gmail.com

Study Locations

• Saudi Arabia
  • Eastern Province
    • Khobar, Eastern Province, Saudi Arabia, 31932
      • Recruiting
      • Hosn Clinics
      • Contact: Mahmoud A. Rageh, MD, PhD; Phone Number: +966535242572; Email: dr.mahmoudrageh@gmail.com
      • Principal Investigator: Mahmoud A. Rageh, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Improvement Assessment (IGA)	Change in investigator-rated global improvement using a 5-point scale ranging from no improvement to almost complete clearance.	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.	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).	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.	Baseline to Month 6

Collaborators and Investigators

• Sponsor: Venus Research Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Estimated): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cosmetic dermatology; Diode laser; Fordyce spots; Sebaceous glands; Lip lesions; 1726 nm laser
• Additional Relevant MeSH Terms: Equipment and Supplies; Lasers; Optical Devices; Radiation Equipment and Supplies; Lasers, Semiconductor
• Other Study ID Numbers: Accure_Fordyce_Spots

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data, including baseline characteristics, lesion counts, and outcome measures, will be shared.
• IPD Sharing Time Frame: Beginning 6 months after publication and available for 5 years.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes