Clinical trial NCT04861246: Evaluation of Laser Treatment for Benign Pigmented Lesions by Non-invasive, Cellular Resolution Optical Coherence Tomography
Official title: Evaluation of Laser Treatment for Benign Pigmented Lesions by Non-invasive, Cellular Resolution Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Benign Pigmented Lesions
Keywords: Optical Coherence Tomograohy
Non-invasive image system
Cellular level resolution
Full-Field OCT
Hyperpigmentation
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Apollo Medical Optics, Ltd
First posted: 2021-04-27
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Static Physician's Global Assessment (PGA)
timeFrame: one and a half years
measure: Dynamic Physician's Global Assessment (PGA)
timeFrame: one and a half years
measure: Subject satisfaction
timeFrame: one and a half years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Taipei Veterans General Hospital
state: Beitou District
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Cheng-Yuan Li, M.D.
role: PRINCIPAL_INVESTIGATOR
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