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A multicenter, prospective, randomized, single-blind, controlled trial for the safety and efficacy of a picosecond Nd:YAG laser in the treatment of benign dermal pigmentary disorder

A multicenter, prospective, randomized, single-blind, controlled trial for the safety and efficacy of a picosecond Nd:YAG laser in the treatment of benign dermal pigmentary disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028601
Enrollment
Unknown
Registered
2019-12-28
Start date
2020-01-31
Completion date
Unknown
Last updated
2020-01-06

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

Conditions

benign dermal pigmentary disorder

Interventions

Experimental group:Picosecond Nd:YAG laser treatment
Control group:Q-switched laser treatment

Sponsors

Hospital for Skin Diseases (Institute of Dermatology), Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years male or female; 2. Diagnosed as nevus of Ota, untreated; 3. Fitzpatrick Skintype III to V; 4. Agree to photograph the treatment area during the study and use it for scientific, educational or other purposes; 5. Patients who have fully understood the study and voluntarily signed the informed consent before participating in the study, and are able to complete all follow-up visits in accordance with the expected treatment procedures.

Exclusion criteria

Exclusion criteria: 1. Highly photosensitive patients, including those who are sensitive to a variety of spectra (visible light, ultraviolet light, infrared light, etc.), especially those who are highly sensitive to light in the infrared wavelength region; 2. Patients with a history of photosensitive epilepsy; 3. Patients whose skin has not returned to normal before treatment, or whose skin is in sensitive skin; 4. Patients with squamous cell carcinoma or melanoma or patients with skin cancer in the expected treatment area; 5. Patients with a history of healing disorders and keloid; 6. Patients with known coagulation dysfunction or thromboembolism; 7. Patients who have taken or are taking anticoagulants or wound-healing medications in the past 6 months; 8. Patients who have taken or are taking drugs (such as psoralen) in the past 6 months that are known to increase light sensitivity; 9. Patients who received systemic or systemic retinole-like therapy such as Accutane or who were scheduled to take it during the first 12 months of treatment; 10. Patients with a history of immunosuppression/immunodeficiency disorders (including HIV infection or AIDS) or who have taken immunosuppressive drugs; 11. Patients who have taken or are taking iron supplements or herbal supplements (such as ginkgo, ginseng or garlic) and fish oil supplements in the past 6 months; 12. Patients with active herpes simplex virus (HSV) in the expected treatment site; 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 has received surgical treatment including: minimally invasive, filling, injection, plastic surgery, or ultraviolet light therapy, intense pulsed light, laser, radio frequency treatment; 15. Screening of patients who had participated in other clinical trials (other than enrolled studies) within the previous 6 months; 16. Pregnant or lactating patients, and both men and women have no family planning during the trial, and agree to use effective contraceptive measures permitted by the program; 17. The investigator considers that the subjects have poor compliance or other organic disease problems that make them unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
Efficacy rate;

Secondary

MeasureTime frame
cure rate;total effective rate;Global Aesthetic Improvement Scale;Pain Visual Analogue Scale;Patient's satisfaction rate;

Countries

China

Contacts

Public ContactTONG LIN

Hospital for Skin Diseases (Institute 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