Evaluation of Laser Treatment for Benign Pigmented Lesions by Non-invasive, Cellular Resolution Optical Coherence Tomography

Taipei Veterans General Hospital

Status: Terminated

Conditions: Benign Pigmented Lesions

Treatments: Device: Laser; Device: ApolloVue® S100 Image System; Device: VISIA®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04861246

2020-08-006C

Details and patient eligibility

About

In recent years, with the maturity of laser technology, laser therapy is one of the popular options for the treatment of pigment diseases. The absorption spectrum of melanin ranges from 300 to 1,000 nm. In past studies, the 532 nm Q-switched Nd:YAG laser is effective for the treatment of superficial melanin. But there are still some side effects in laser treatment, such as post-inflammation pigmentation (PIH), depigmentation, skin redness, etc., and PIH is particularly likely to occur on darker skin. However, there is still no good evidence as to what factors or laser treatments can cause PIH.

Therefore, in this study, we will use ApolloVue® S100 Image System (ApolloVue® S100 Image System is a medical device class II) to scan before and after skin of laser treatment to observe the changes in the skin condition. By observing and analyzing these changes, as a evaluation of predictors or prognostic factors after laser treatment and whether PIH will occur.

Enrollment: 10 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≧ 20
• Both gender are accepted
• Subject with pigmented diseases
• The pigmented lesions which participating the trial were not treated in the last 12 months
• Accepts not to expose the face to sunlight or artificial UV rays during the study
• Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits
• During the trial period, willing to use the maintenance and sunscreen products provided in this trial for care

Exclusion criteria

• Pregnant woman or woman wishing to be pregnant during the study, or during breastfeeding period
• Has any condition which, in the investigator's opinion, would make it unsafe for participating in this research study
• Has systemic skin disorders or infections
• Is enrolled or accepted other investigational drug or medical device

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Experimental

Experimental group

Description:

Epidermal pigmented lesion

Treatment:

Device: VISIA®

Device: ApolloVue® S100 Image System

Device: Laser