Efficacy of infraorbital darkening treatment using multi-pulsed Q-switched 1064-nm Nd:YAG laser

Phase 3

Not yet recruiting

• Conditions: Patients with a history of infraorbital darkening diagnosed by dermatologist at least 1 year; Infraorbital darkening, Q-switched 1064-nm Nd:YAG laser, fractional Q-switched laser, neocollagenesis, infraorbital rejuvenation, infraorbital volume

• Registration Number: TCTR20230821003
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-21
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Healthy patient with a history of infraorbital darkening diagnosed by dermatologist at least 1 year
- Fitzpatrick skin type II to IV

Exclusion Criteria

- Signs of active infection or inflammation around the eyes
- Diseases related to infraorbital darkening
- Active systemic severe medical diseases/ photosensitivity such as liver cirrhosis, thalassemia, systemic lupus erythematosus and dermatomyositis
- Drug-induced hyperpigmentation such as hydroxychloroquine, chloroquine, gold or zidovudine
- History of any ocular or periocular surgery e.g. blepharoplasty or treatment of fat herniation
- History of abnormal wound healing process such as poor controlled diabetes mellitus or smoking
- History of atopy
- Pregnancy and lactation
- Immunocompromised host/status
- Sleep disorders such as sleep disturbance or narcolepsy
- Use of oral retinoids within 6 months
- Use of nonsteroidal antiinflammatory drugs, steroids, anticoagulants, blood thinning agents and topical whitening agents within 1 months.
- Previous laser treatment, chemical peels or transepidermal whitening agents within 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
skin lightness baseline, 1 month after final session of laser Chromameter

Secondary Outcome Measures

Name	Time	Method
Infraorbital volume baseline, 1 month after final session of laser Croma infraorbital hollow assessment ,Elevation and depression volume baseline, 1 month after final session of laser Antera 3D,skin color (red,blue,green) baseline, 1 month after final session of laser Chromameter,Improvement scale 1 month after final session of laser 6-graded improvement scale (deteriorating, worsening, neutral, no improvement, poor, fair, good, and excellent),Patient's satisfaction score 1 month after final session of laser 4-point scale (dissatisfied, fair slightly satisfied, intermediately satisfied, and very satisfied)