A Novel 532-nm Picosecond Laser for Freckle Treatment in Chinese Patients (PICO-FRECK-C)

Beijing Hospital

Status: Completed

Conditions: Freckles

Treatments: Device: Nd:YAG Picosecond Laser Therapy System; Device: Nd:YAG Picosecond Laser Therapy Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07352631

MLDPMQB-01 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 in the treatment area within the past 1 month.
• Pregnancy, lactation, or planning pregnancy during the study period.
• Participation in another clinical trial (except registry studies) within 3 months prior to screening.
• Considered by the investigator to have poor compliance or otherwise unsuitable for participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Investigational Laser Device

Experimental group

Description:

Participants received treatment with the investigational Nd:YAG picosecond laser therapy device (Model: MLD picolander). The device emits light at a wavelength of 532 nm and was used according to the manufacturer's instructions and clinical judgment to treat freckles in the designated target area on one side of the face.

Treatment:

Device: Nd:YAG Picosecond Laser Therapy Device

Control Laser Device

Active Comparator group

Description:

Participants received treatment with the active control device, the marketed Nd:YAG picosecond laser therapy system (Model: PicoWay). This device also emits light at a wavelength of 532 nm and was used according to its approved instructions and clinical judgment to treat freckles in the symmetrical target area on the contralateral side of the face.

Treatment:

Device: Nd:YAG Picosecond Laser Therapy System