Fordyce SpotsNCT07300917
1726-nm Diode Laser for Lip Fordyce Spots
A study testing Accure 1726-nm Diode Laser in people with Fordyce Spots, run by Venus Research Center at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fordyce Spots
- What is being tested?
- Accure 1726-nm Diode Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Hosn Clinics
Khobar, Eastern Province, 31932
Mahmoud A. Rageh, MD, PhD, +966535242572, dr.mahmoudrageh@gmail.com
Mahmoud A. Rageh, MD, PhD
About this study
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
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.
Read the 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.
- Conditions
- Fordyce Spots
- Being tested
- Accure 1726-nm Diode Laser
- Keywords
- Fordyce spots, Sebaceous glands, Lip lesions, Cosmetic dermatology, Diode laser, 1726 nm laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accure 1726-nm Diode LaserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Accure 1726-nm Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (4)
Investigator Global Improvement Assessment (IGA)
Change in investigator-rated global improvement using a 5-point scale ranging from no improvement to almost complete clearance.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fordyce SpotsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Rageh, Venus Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300917
- Sponsor's protocol ID
- Accure_Fordyce_Spots
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data, including baseline characteristics, lesion counts, and outcome measures, will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07300917
- Acronym / sponsor ID
- Accure_Fordyce_Spots
- Conditions
- Fordyce Spots
- Keywords
- Fordyce spots, Sebaceous glands, Lip lesions, Cosmetic dermatology, Diode laser, 1726 nm laser
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Venus Research CenterUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accure 1726-nm Laser Treatment | Experimental | Device: Accure 1726-nm Diode LaserParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accure 1726-nm Diode LaserA 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. | Device | Accure 1726-nm Laser Treatment |
Primary outcome
Percentage Reduction in Fordyce Spot Count
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including baseline characteristics, lesion counts, and outcome measures, will be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accure 1726-nm Diode Laser in people with Fordyce Spots, run by Venus Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud A. Rageh, MD, PhD (+966535242572, dr.mahmoudrageh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Reduction in Fordyce Spot Count (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.