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Safety and efficacy of Nd: YAG picosecond laser in the treatment of Benign Epidermic Hyperpigmented diseases: a randomized, blind, self-controlled, two-center study

Safety and efficacy of Nd: YAG picosecond laser in the treatment of Benign Epidermic Hyperpigmented diseases: a randomized, blind, self-controlled, two-center study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039037
Enrollment
Unknown
Registered
2020-10-14
Start date
2020-10-16
Completion date
Unknown
Last updated
2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Epidermic Hyperpigmented diseases

Interventions

1:Nd:YAG picosecond laser (PicoWay)
2:Alexandrite picosecond laser (picosure)

Sponsors

Hospital of Dermatology, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18 ~ 65 years old (inclusive) , sex is not limited; 2. Fitzpatrick skin type III-V; 3. Patients diagnosed with facial freckles; 4. Patients with symmetrical bilateral facial freckles; 5. Patients who agreed to be photographed in the treatment area during the study. 6. Participants who were well informed before participating in the study and who voluntarily signed informed consent forms were able to follow the expected treatment protocol and complete all follow-up;

Exclusion criteria

Exclusion criteria: 1. Highly photosensitive patients include those who are sensitive to all kinds of spectrum (visible light, ultraviolet light, infrared light, etc.), especially those who are highly sensitive to light in the near-infrared and infrared wavelength regions. 2. Patients with a history of photosensitive epilepsy. 3. Patients whose skin has not returned to normal or whose skin is in sensitive condition before treatment. 4. Patients with squamous-cell Carcinoma or melanoma or with skin cancer as the area of treatment to be expected. 5. Patients with a history of healing problems and Keloids. 6. Patients with known Coagulopathy or thromboembolic disorders. Kill. Patients who have taken or are taking anticoagulants or medications that affect wound healing in the past 6 months. 8. Patients who have taken or are taking medications known to increase photosensitivity, such as PSORALEN, in the past 6 months. 9. Patients who have received systemic or systemic retinoids therapy such as isotretinoin (Accutane) or who plan to take it during treatment in the past 12 months. 10. Patients with a history of immunosuppressive/immune disorders, including HIV infection or AIDS, or who have taken immunosuppressive drug. 11. Patients who have taken or are taking iron or herbal supplements (such as Ginkgo, Ginseng or garlic supplements) and fish oil supplements in the past 6 months. 12. Patients with active Human herpesvirus 1 in the desired treatment area. 13. Patients with active local or systemic infection or open wounds in the area to be treated. 14. In the past 3 months, the treatment area underwent surgery including: minimally invasive, filling, injection, plastic surgery, or ultraviolet phototherapy, intense pulsed light, laser, and radio frequency therapy. 15. Patients who participated in other clinical trials (except for registered studies) within 6 months prior to screening. 16. Pregnant or lactating women. 17. The researchers considered that the patients with poor compliance or other organic diseases were not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
The lesion clearance rate;

Countries

China

Contacts

Public ContactTong Lin

Hospital of Dermatology, Chinese Academy of Medical Sciences

ddlin@hotmail.com+86 13951902258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026