Melasma is a common acquired hyperpigmentary skin disorder, clinically manifested as symmetric brown or gray-brown macules on sun-exposed areas including the cheeks, forehead and upper lip.
Conditions
Interventions
Control group:The control group of the subjects randomly received salicylic acid treatment on half of their faces and did not receive 1565nm non-ablative fractional laser
experimental group:The experimental group of the subjects randomly received salicylic acid and 1565 nm non-ablative fractional laser on half of their faces.
Sponsors
Shenzhen Center for Chronic Disease Control
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Aged 20–60 years, male or female; 2.Clinically diagnosed with facial melasma; 3.Assessable lesions present on both cheeks with roughly symmetrical baseline severity; 4.Predominantly Fitzpatrick skin phototype III–IV; 5.Duration of melasma no less than 6 months, with lesions remaining stable over the past 3 months; 6.Judged by the investigator to be suitable for split-face self-controlled trial; 7.Willing to follow unified photoprotection and skincare regimens and refrain from other relevant treatments during the study period; 8.Able to complete follow-up visits, clinical photography and skin examinations as required by the study; 9.Signed written informed consent form;
Exclusion criteria
Exclusion criteria: 1.Pregnant, lactating subjects or those planning pregnancy in the near future; 2.Subjects who have received facial laser, intense pulsed light (IPL), radiofrequency, microneedling, chemical peeling or other treatments that may interfere with efficacy evaluation in the past 3 months; 3.Subjects who have used topical agents affecting pigment assessment (e.g., hydroquinone, tretinoin, azelaic acid, high-concentration fruit acid, salicylic acid, etc.) within the past 1 month and cannot complete the washout period; 4.Those who have taken systemic isotretinoin, tranexamic acid, glucocorticoids, oral contraceptives or other drugs that may interfere with study results in the last 3 months will be excluded, unless standardized treatment will be adopted and used consistently by all subjects. 5.Subjects with active facial infection, obvious dermatitis, acute exacerbation of rosacea, open wounds, or keloid predisposition; 6.Subjects with known allergy to salicylic acid, aspirin, or ingredients of the investigational product; 7.Subjects with photosensitive diseases, or a history of significant sun exposure or sunburn recently; 8.Subjects complicated with severe systemic diseases or psychological conditions, who are deemed ineligible for participation by the investigator; 9.Any other conditions judged by the investigator that may affect compliance, safety or efficacy evaluation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the between-side difference in the change from baseline in the modified Melasma Area and Severity Index (mMASI) score at Week 12 between the investigational side (sali; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction score;Physician's global assessment (PGA);the melasma quality of life scale (MELASQoL);mMASI(modified Melasma Area and Severity Index,mMASI) score; | — |
Countries
China
Contacts
Public ContactGuan yang
Shenzhen Center for Chronic Disease Control
Outcome results
None listed