FrecklesPICO-FRECK-CNCT07352631
A Novel 532-nm Picosecond Laser for Freckle Treatment in Chinese Patients
A study testing Nd:YAG Picosecond Laser Therapy Device and Nd:YAG Picosecond Laser Therapy System in people with Freckles, run by Beijing Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Freckles
- What is being tested?
- Nd:YAG Picosecond Laser Therapy Device and Nd:YAG Picosecond Laser Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesChina
- Study dates
- 11 Dec 2024to 27 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 1 country.
China2 sites
Beijing Hospital
Beijing
Bengbu First People's Hospital
Bengbu, Anhui
About this study
Official title: Efficacy and Safety of a Novel 532-nm Picosecond Nd:YAG Laser for the Treatment of Freckles in Chinese Patients: A Prospective, Randomized, Split-Face Controlled Study
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:
Read more
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
- Being tested
- Nd:YAG Picosecond Laser Therapy Device, Nd:YAG Picosecond Laser Therapy System
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd:YAG Picosecond Laser Therapy DeviceDevice
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.
Nd:YAG Picosecond Laser Therapy SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Nd:YAG Picosecond Laser Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks after the single treatment session
Secondary outcomes (4)
Complete Clearance Rate at 8 Weeks
The proportion of participants achieving complete clearance of freckles at the 8-week follow-up visit. Complete clearance is defined as a lesion clearance rate of 90% 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.
Measured: 8 weeks after the single treatment session
Global Aesthetic Improvement Scale (GAIS) Score at 8 Weeks
The overall improvement in aesthetic appearance of the treated areas as assessed by blinded evaluators at the 8-week follow-up visit, using the Global Aesthetic Improvement Scale (GAIS). The GAIS is a 5-point scale ranging from 1 (Worse) to 5 (Very Much Improved).
Measured: 8 weeks after the single treatment session
Pain Score During Treatment (VAS)
The level of pain experienced by participants during the laser treatment, assessed immediately (within 30 minutes) after the treatment using a Visual Analogue Scale (VAS). The VAS is a continuous scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Immediately after the single treatment session (within 30 minutes)
Participant Satisfaction Score at 8 Weeks
The degree of participant satisfaction with the treatment results regarding pigment clearance, assessed at the 8-week follow-up visit using a satisfaction survey. The score ranges from 1 (completely dissatisfied) to 5 (very satisfied).
Measured: 8 weeks after the single treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start11 Dec 2024
- Primary completion12 Jun 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrecklesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352631
- Sponsor's protocol ID
- MLDPMQB-01
- Other IDs
- MLDPMQB-01
- Acronym
- PICO-FRECK-C
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. Privacy and Confidentiality: The data contain sensitive personal health information of participants, and sharing such data may compromise participant privacy and confidentiality. 2. Commercial and Regulatory Constraints: The trial is sponsored by a medical device company, and the data are subject to intellectual property protection and ongoing regulatory review processes. 3. Lack of Data Sharing Mechanism: There is currently no established infrastructure or agreement for external data sharing in this trial.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Novel 532-nm Picosecond Nd:YAG Laser for the Treatment of Freckles in Chinese Patients: A Prospective, Randomized, Split-Face Controlled Study
- ClinicalTrials.gov ID
- NCT07352631
- Acronym / sponsor ID
- PICO-FRECK-C / MLDPMQB-01
- Conditions
- Freckles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 20 Jan 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Laser Device | Experimental | Device: Nd:YAG Picosecond Laser Therapy DeviceParticipants 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. |
| Control Laser Device | Active comparator | Device: Nd:YAG Picosecond Laser Therapy SystemParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| Nd:YAG Picosecond Laser Therapy DeviceThis 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. | Device | Investigational Laser Device |
| Nd:YAG Picosecond Laser Therapy SystemThis 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. | Device | Control Laser Device |
Primary outcome
Treatment Response Rate at 8 Weeks
Time frame: 8 weeks after the single treatment session
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.
4 secondary outcomes
Complete Clearance Rate at 8 Weeks
Time frame: 8 weeks after the single treatment session
Global Aesthetic Improvement Scale (GAIS) Score at 8 Weeks
Time frame: 8 weeks after the single treatment session
Pain Score During Treatment (VAS)
Time frame: Immediately after the single treatment session (within 30 minutes)
Participant Satisfaction Score at 8 Weeks
Time frame: 8 weeks after the single treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 1. Privacy and Confidentiality: The data contain sensitive personal health information of participants, and sharing such data may compromise participant privacy and confidentiality. 2. Commercial and Regulatory Constraints: The trial is sponsored by a medical device company, and the data are subject to intellectual property protection and ongoing regulatory review processes. 3. Lack of Data Sharing Mechanism: There is currently no established infrastructure or agreement for external data sharing in this trial.
Related trials for Freckles
Active, not recruitingObservational study
Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs
Skin Cancer, Complication
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nd:YAG Picosecond Laser Therapy Device and Nd:YAG Picosecond Laser Therapy System in people with Freckles, run by Beijing Hospital at 2 sites in China.
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 6 inclusion and 18 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: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Response Rate at 8 Weeks (time frame: 8 weeks after the single treatment session). 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 21 Jan 2026.