Trials / Terminated
TerminatedNCT04861246
Evaluation of Laser Treatment for Benign Pigmented Lesions by Non-invasive, Cellular Resolution Optical Coherence Tomography
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Taipei Veterans General Hospital, Taiwan · Other Government
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Laser | The device will be used to do Laser treatment. To compare the therapeutic effect to laser treatment before and post treatment for 14 and 60 days. |
| DEVICE | ApolloVue® S100 Image System | The device is an in vivo non-invasive optical coherence tomography and will be used to obtain OCT images before and after laser treatment of skin. |
| DEVICE | VISIA® | The device is skin analysis system and will be used to obtain before and after images of laser treatment. |
Timeline
- Start date
- 2021-09-15
- Primary completion
- 2022-03-22
- Completion
- 2022-03-22
- First posted
- 2021-04-27
- Last updated
- 2022-07-21
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04861246. Inclusion in this directory is not an endorsement.