Melasma
Conditions
Interventions
trial group:Superpicosecond combined with Beluga Micron condensate permeable extract
Control group:Superpicosecond plus placebo
Sponsors
Shanghai Jiahui International Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese subjects aged 18-60 years. 2. Subjects with Fitzpatrick skin type II-V and pure pigmented melasma on both sides. 3. The severity of melasma on both sides was consistent. 4. Subjects intending for long-term treatment of melasma and planning to receive superpicosecond treatment. 5. Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures. 6. Subjects understand the nature of the study and sign the ICF.
Exclusion criteria
Exclusion criteria: 1. Subjects with facial melasma in active stage. 2. Subjects with a history of skin pigmentation, such as pigmentation caused by sex hormonal factors (pregnancy, oral contraceptives). 3. Subjects with autoimmune disease, endocrine disease or liver disease that may cause changes in skin color. 4. Used skin whitening agents/steroids/phototoxic drugs and received laser/systemic melasma treatment within 3 months before enrollment. 5. Subjects with known contraindications to superpicosecond treatment. 6. Subjects with known infection at the site of the proposed treatment. 7. Female subjects who are pregnant, breastfeeding or planning to become pregnant. 8. Subjects who plan to use other drugs or skin care products that affect skin color or plan to undergo other laser treatments or sunbathing during the treatment. 9. Subjects participating in clinical trials of other drugs or medical devices. 10. Other subjects who are not suitable to participate in this study as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Melasma Area and Severity Index (hemi-MASI) score at week 14 after first treatment with ultra-picoseconds; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of hemi-MASI score after skin care treatment compared with the baseline level (week2\6\10));Changes in melanin index (MI) after skin care treatment from baseline (weeks 2, 6, 10 and 14);Changes in hydration from baseline after skin care treatment (weeks 2, 6, 10 and 14);Changes in transepidermal water loss from baseline after skin care treatment (weeks 2, 6, 10 and 14);Changes in gloss from baseline after skin care treatment (weeks 2, 6, 10 and 14);Investigator's overall evaluation (0-4 points) after skin care treatment (week10?14);Overall satisfaction of subjects after treatment (week 10?14); | — |
Countries
China
Contacts
Public ContactMichelle Ding
Shanghai Jiahui International Hospital
Outcome results
None listed