nevus of Ota
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) aged 18 to 65 years old, male or female; 2) clear clinical diagnosis, no previous treatment of dermal pigmented skin diseases, such as: nevus of Ota; 3) Fitzpatrick Skin Type III ~ V; 4) The subjects agreed not to undergo any facial surgery or treatment other than the test treatment during the treatment and observation period; 5) Subjects can understand and follow the test requirements throughout the whole process and can cooperate fully; 6) Subject voluntarily participated in the study and signed an informed consent.
Exclusion criteria
Exclusion criteria: 1) there is a scar or mark in the treated part of the subject, which affects the observation of the curative effect; 2) subjects with other skin diseases or infections on the face; 3) light-sensitive or prone to light-induced epilepsy; 4) oral administration of vitamin A drugs within six months; 5) have been exposed to sunlight within six months; 6) have a history of serious allergies or have a history of blood diseases, taking drugs that interfere with coagulation; 7) subjects with compromised immunity; 8) subjects with hypertrophic scar or a history of keloid; 9) subjects had previous adverse effects on prilocaine or lidocaine products (this exclusion does not apply to subjects not using prilocaine or lidocaine products); 10) subjects have severe cardiovascular, gastrointestinal, respiratory, endocrine or central nervous system disorders and mental disorders that may have adverse effects on this clinical trial; 11) Participants participated in other clinical studies within 30 days prior to the screening date (this subject is not eligible if participating in other clinical cosmetology studies within 6 months); 12) Subjects did not agree with contraceptive measures during the study period (medically acceptable methods of contraception: condom use, continuous use of oral contraceptives for more than 3 months, injection or implantation of contraceptive devices, placement of IUDs (IUD); 13) pregnant or lactating female subjects; 14) Researchers consider the subject is not fit to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| lesion clearance; | — |
Secondary
| Measure | Time frame |
|---|---|
| cure rate;Global Aesthetic improvement scale;degree of ache;satisfaction of patients; | — |
Countries
China
Contacts
Dermatology Hospital, Chinese Academy of Medical Sciences