Melasma
Conditions
Interventions
trial group:Ultra-Picoway combined with Skinceuticals skin care products
Control group:Ultra-Picoway combined with regular moisturizing sunscreen products
Sponsors
Shanghai Jiahui International Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Chinese subjects aged 18-65 years old. 2. Subjects with Fitzpatrick skin type II-V with simple pigmented melasma on both sides. 3. The severity of melasma on both sides of the face was the same. 4. Subjects who are interested in long-term melasma treatment and plan to undergo ultra-picosecond treatment. 5. Subjects are willing to follow the study protocol and complete the appropriate procedures. 6. The subject understands the nature of the study and signs an informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Subjects with active facial melasma. 2. Subjects with a history of skin pigmentation, such as pigmentation caused by sex hormonal factors (pregnancy, oral contraceptives). 3. Subjects with autoimmune diseases, endocrine diseases or liver diseases that may cause skin tone changes, such as hepatitis, nephritis, systemic lupus erythematosus (SLE), etc. 4. Have used skin lighteners/steroids/phototoxic drugs, received laser/systemic melasma treatment within 3 months prior to enrollment. 5. Subjects with known contraindications to hyperdermabrasion or CE/DD/242 use (e.g., allergy to skin care combination ingredients). 6. Subjects with known infection in the area to be treated. 7. Female subjects who are pregnant, breastfeeding or planning to become pregnant (within 3 months). 8. Subjects who are planning to use other drugs that affect their skin tone during treatment or who are planning to undergo other laser treatments or tanning. 9. Subjects who are participating in clinical trials of other drugs or medical devices. 10. Other subjects who have been evaluated by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Melasma Area and Severity Index (hemi-MASI) score at week 12 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 (week4 &8));Changes in melanin index (MI) after skin care treatment from baseline (weeks 4, 8, and 12);Changes in hydration from baseline after skin care treatment (weeks 4, 8, and 12);Changes in transepidermal water loss from baseline after skin care treatment (weeks 4, 8, and 12);Changes in gloss from baseline after skin care treatment (weeks 4, 8, and 12);Investigator's overall evaluation (0-6 points) after skin care treatment (week 4, 8, 12);Overall satisfaction of subjects after treatment (week 4, 8, 12); | — |
Countries
China
Contacts
Public ContactMichelle Ding
Shanghai Jiahui International Hospital
Outcome results
None listed