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

NCT07352631 | Completed

• 1 other identifier: MLDPMQB-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Freckles

Outcome Measures

Primary Outcomes (1)

• Treatment Response Rate at 8 Weeks

  The proportion of participants achieving a treatment response at the 8-week follow-up visit. A response is defined as a lesion clearance rate of 60% or greater. The clearance rate is calculated as: \[(Number of freckles at baseline - Number of freckles at 8 weeks) / Number of freckles at baseline\] x 100%. Assessment is performed by blinded evaluators based on standardized photographs.

  8 weeks after the single treatment session

Secondary Outcomes (4)

• Complete Clearance Rate at 8 Weeks

  8 weeks after the single treatment session

• Global Aesthetic Improvement Scale (GAIS) Score at 8 Weeks

  8 weeks after the single treatment session

• Pain Score During Treatment (VAS)

  Immediately after the single treatment session (within 30 minutes)

• Participant Satisfaction Score at 8 Weeks

  8 weeks after the single treatment session

Study Arms (2)

Investigational Laser Device

EXPERIMENTAL

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.

Device: Nd:YAG Picosecond Laser Therapy Device

Control Laser Device

ACTIVE COMPARATOR

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.

Device: Nd:YAG Picosecond Laser Therapy System

Interventions

Nd:YAG Picosecond Laser Therapy Device DEVICE

This is an investigational medical device. It is a Nd:YAG laser system that generates picosecond-duration pulses of light at a wavelength of 532 nanometers (nm). It is designed for the treatment of benign epidermal pigmented lesions, including freckles, through selective photothermolysis and photomechanical effects.

Investigational Laser Device

Nd:YAG Picosecond Laser Therapy System DEVICE

This is a marketed (approved) medical device used as an active comparator. It is a Nd:YAG laser system that generates picosecond-duration pulses of light at a wavelength of 532 nanometers (nm). It is indicated for the treatment of benign epidermal pigmented lesions, including freckles.

Control Laser Device

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (2)

Bengbu First People's Hospital

Bengbu, Anhui, China

Location

Beijing Hospital

Beijing, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 20, 2026
• Study Start: December 11, 2024
• Primary Completion: June 12, 2025
• Study Completion: August 27, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)