Partial Unilateral Lentiginosis
Conditions
Interventions
Zoom lens array treatment group:755-nm picosecond alexandrite laser with Zoom lens array for Treating primary localized cutaneous amyloidosis
5-mm DLA treatment group:755-nm picosecond alexandrite laser with 5-mm diffractive lens array for treating partial unilateral lentiginosis
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years (inclusive), regardless of gender; 2.Clinically or dermoscopically confirmed unilateral lentiginosis; 3.Disease duration >= 6 months; 4.Fitzpatrick-Pathak skin phototype III to V; 5.Willing and able to comply with the study requirements, including understanding and adhering to research procedures, following restrictions and educational instructions, undergoing laser treatments as prescribed, completing scheduled follow-ups, and providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Active bacterial, viral (such as herpes), or fungal infection in the treatment area; 3. Patients with other skin conditions at the affected area that could affect the evaluation of the efficacy of unilateral freckle-like nevus (such as freckles, Ota nevus, café-au-lait spots, etc.) or require concurrent treatment (such as psoriasis, eczema, melanoma, etc.); 4. History of post-inflammatory hyperpigmentation, poor wound healing, or hypertrophic scars; 5. Excessive sun exposure within the past 4 weeks; 6. History of photosensitive skin disease or use of photosensitizing drugs within the past 6 months; 7. The treatment area has been treated with topical drugs (such as hormones, retinoids, tranexamic acid, salicylic acid, etc.) in the past 1 month, or has undergone phototherapy, laser therapy, or surgical treatment in the past 3 months; 8. Use of immunosuppressants, hormones, or vitamin A derivatives within the past 3 months; 9. History of any uncontrolled or clinically significant systemic disease or surgery that could affect treatment or efficacy evaluation, such as diseases of the circulatory, nervous, hematologic, immune, or psychiatric systems; 10. Participation or ongoing participation in other interventional drug or medical device clinical trials within the past 3 months without withdrawal; 11. Presence of severe mental illness, cognitive impairment, or history of drug abuse that may affect understanding, compliance, or safety reporting; 12. Any other conditions considered by the investigator to potentially affect compliance or make the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of lentiginous lesions at 12 weeks following the final treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate of lentigines at 20 weeks after initial treatment;The Antera 3D system was used to measure lesion area, papule height and volume, skin roughness, and the pigmentation index.;Lentigines Improvement Scale Score;Adverse events; | — |
Countries
China
Contacts
Public ContactZhenfeng Liu
Dematology Hospital of Southern Medical University
Outcome results
None listed