CompletedNot Applicable

A Novel 532-nm Picosecond Laser for Freckle Treatment in Chinese Patients

China84 participantsStarted 2024-12-11

Plain-language summary

The goal of this clinical trial was to learn if a novel laser device works as well and is as safe as an already approved laser device for removing freckles on the face. The main questions it aimed to answer were: After 8 weeks, did the novel laser make freckles fade by 60% or more for a similar number of participants as the approved laser? What side effects did participants have from either laser? Researchers compared the results from two sides of each participant's face to see if the novel laser worked as well as the approved laser. One side of the face was treated with the novel laser, and the other side was treated with the approved laser. A computer randomly chose which side received which laser. Participants in this study: Were adults (aged 18-65) with similar freckles on both sides of their face. Received one laser treatment session, using the two different lasers on opposite sides of their face. Returned to the clinic for check-up visits about 4 weeks and 8 weeks after the treatment. Had photos taken of their face at each visit so doctors could compare the fading of their freckles. Answered questions about any pain during the treatment and their satisfaction with the results.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 to 65 years (inclusive). * Fitzpatrick skin type III, IV, or V. * Diagnosed with facial freckles. * Presence of visually symmetrical bilateral facial freckles. * Able to understand and voluntarily sign the informed consent form. * Willing and able to comply with all study procedures and follow-up visits. Exclusion Criteria: * High photosensitivity to any light spectrum. * Severe organic diseases (e.g., epilepsy, psychosis). * History of sunburn within the past 1 month. * History of skin malignancies (e.g., squamous cell carcinoma, melanoma). * Skin lesions that are broken, inflamed, or with a history of poor wound healing or keloids. * Diagnosis of cutaneous lupus erythematosus. * Significant systemic disease or obvious lesions in the treatment area. * Presence of herpes simplex virus (HSV) in the expected treatment area. * Active local or systemic infection, or open wounds in the treatment area. * History of immunosuppression/immunodeficiency (including HIV/AIDS) or use of immunosuppressive drugs. * Use of anticoagulants or medications that may alter wound healing within the past 1 month. * Use of known photosensitizing medications within the past 1 month. * Oral isotretinoin (Accutane) use within 12 months prior to initial treatment or planned use during the study. * Use of iron supplements, herbal supplements (e.g., Ginkgo, Ginseng, Garlic), or fish oil supplements within the past 1 month. * Other photo or energy-based aesthetic procedures …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment Response Rate at 8 Weeks

Timeframe: 8 weeks after the single treatment session

Trial details

NCT IDNCT07352631

SponsorBeijing Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-06-12

View on ClinicalTrials.gov More Freckles trials