melasma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Women aged 25–60 years. 2.Good general health status. 3.Diagnosed with melasma and facial inflammation according to standard criteria. 4.Agree to avoid excessive sun exposure during the study period. 5.Willing to comply with all study requirements, complete the full 2-month trial, and attend all scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breastfeeding women. 2.Known allergy to any ingredients commonly found in cosmetics or toiletries—such as soaps, rubber, alcohol, fragrances, lotions, or other topical medications. 3.Presence of dermatological conditions (e.g.psoriasis, eczema, skin cancer) or open wounds, abrasions, or infections in or near the test area. 4.Use of topical depigmenting agents within 2 weeks prior to enrollment, or use of systemic retinoids, tranexamic acid, chemical peels, injections, laser therapy, or similar procedures within 3 months prior to enrollment. 5.Participation in any other clinical trial within the past 6 months. 6.Pregnant or breastfeeding women (duplicate of item 1; retained for completeness). 7.Women currently taking oral contraceptives. 8.Abnormal liver or kidney function, or any systemic disease that may interfere with the study outcomes. 9.Individuals with unrealistically high expectations of treatment efficacy. 10.Patients whose melasma has previously shown poor response to standard first-line therapies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Melasma Area and Severity Index (mMASI) assessment;Physician's Global Assessment (PGA): Lesional Clearance Rate Evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin physiological parameter analyses: Melasma Melanin Index (MI) Melasma color chromaticity (Lab* values) Individual Typology Angle (ITA°) Transepidermal water loss (TEWL) Stratum corneum hydration;VISIA imaging: brown spots and UV spots;Patient satisfaction and Dermatology Life Quality Index (DLQI); | — |
Countries
China
Contacts
West China Hospital, Sichuan University