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A split-face study comparing the incidence of postinflammatory hyperpigmentation following a 532-nm Picosecond laser: broad-spectrum vs. broad-spectrum with iron oxide sunscreens

Phase 4
Conditions
Solar lentigines
PIH
Visible light
Sunscreen
Registration Number
TCTR20230417004
Lead Sponsor
Skinova Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Enrolling by invitation
Sex
All
Target Recruitment
30
Inclusion Criteria

1. Asian with Fitzpatrick Skin type III-V
2. Was diagnosed by a physician as Solar lentigines
3. There are solar lentigines lesions on both sides of the face. The lesion size is greater than 6 mm.

Exclusion Criteria

1. Pregnant women
2. Patients with dermatitis, wounds, or skin infections on the face
3. Patients with a history of allergy to anesthetics that cannot use cold air during treatment instead.
4. Patients with a history of allergy to sunscreen or iron oxide allergy
5. Patients with other diseases related to pigmentation abnormalities, such as melasma, hori nevus, nevus of ota, freckles, etc., in the same area as solar lentigines
6. Patients with a history of herpes on the face or suffering from herpes on the face
7. Patients with mental disorders whom a psychiatrist has diagnosed.
8. Patients considered by the researcher to be unsafe if participating in the program
9. Patients who are not allowed to take pictures for treatment evaluation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of PIH 2 weeks, 4 weeks, 8 weeks, 12 weeks after treatment Clinical evaluation
Secondary Outcome Measures
NameTimeMethod
Average melanin concentration Before treatment, 2 weeks, 4 weeks, 8 weeks, 12 weeks after treatment Antera 3D analysis,Melanin index Before treatment, 2 weeks, 4 weeks, 8 weeks, 12 weeks after treatment Mexameter MX 18
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