Melasma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meeting the diagnostic criteria for melasma, as confirmed by a dermatologist. (2) The primary affected areas are both cheeks, with typical melasma lesions visible and symmetrically distributed. (3) Aged between 30 and 55 years, with overall good health. (4) Voluntary participation, willing to provide written informed consent, and able to read, speak, write, and understand Chinese. (5) Willing to cooperate and participate, adhere to the study requirements during the research period, and promptly report any changes in health status or symptoms or reactions related to adverse events.
Exclusion criteria
Exclusion criteria: (1) Having undergone laser skin resurfacing, chemical peels, dermal filler injections, or any other procedures that may affect cutaneous vascular proliferation within 6 months prior to enrollment. (2) Use of any topical medications on the face for treating pigmented lesions or other conditions, or use of photosensitizing drugs or products, facial bleaching products, ultraviolet light therapy, topical prescription medications, or topical or systemic retinoids for redness or pigmentation within 30 days prior to study participation. Additionally, patients with history of lesion exacerbation induced by sun exposure are also excluded. (3) Facial health conditions and/or pre-existing or potential skin diseases (e.g., psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe scarring) that, in the investigator’s opinion, make the individual unsuitable for participation or may interfere with the study results. (4) History of immunosuppression/immunodeficiency, including HIV infection or acquired immunodeficiency syndrome, or current use of immunosuppressive medications and/or a documented history of radiation dermatitis as determined by study records. (5) Uncontrolled medical conditions such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism. Individuals with multiple concurrent health conditions may be excluded, even if controlled by diet or medication. (6) Individuals with observable facial tanning, scarring, moles, excessive hair growth, or other skin conditions that, in the investigator’s opinion, may affect the test results. (7) Poor adherence or inability to cooperate with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area and severity of unilateral facial melasma were scored, Hemi-MASI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Melasma Classification;Clinical Erythema Assessment;Dermoscopy Score;Reflectance Confocal Microscopy Assessment;Digital Deglare Technique Score;Melasma Life Quality Index ;Numerical Rating Scale;Patient Global Assessment; | — |
Countries
China
Contacts
The Third Xiangya Hospital, Central South University