Evaluation of Laser Treatment for Benign Pigmented Lesions by Non-invasive, Cellular Resolution Optical Coherence Tomography
NCT ID: NCT04861246
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2021-09-15
2022-03-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Experimental
Epidermal pigmented lesion
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.
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.
VISIA®
The device is skin analysis system and will be used to obtain before and after images of laser treatment.
Interventions
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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.
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.
VISIA®
The device is skin analysis system and will be used to obtain before and after images of laser treatment.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Apollo Medical Optics, Ltd
INDUSTRY
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Principal Investigators
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Cheng-Yuan Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Locations
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Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan
Countries
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References
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Vashi NA, Kundu RV. Facial hyperpigmentation: causes and treatment. Br J Dermatol. 2013 Oct;169 Suppl 3:41-56. doi: 10.1111/bjd.12536.
Vachiramon V, Panmanee W, Techapichetvanich T, Chanprapaph K. Comparison of Q-switched Nd: YAG laser and fractional carbon dioxide laser for the treatment of solar lentigines in Asians. Lasers Surg Med. 2016 Apr;48(4):354-9. doi: 10.1002/lsm.22472. Epub 2016 Jan 12.
Wang CC, Sue YM, Yang CH, Chen CK. A comparison of Q-switched alexandrite laser and intense pulsed light for the treatment of freckles and lentigines in Asian persons: a randomized, physician-blinded, split-face comparative trial. J Am Acad Dermatol. 2006 May;54(5):804-10. doi: 10.1016/j.jaad.2006.01.012.
Kang HJ, Na JI, Lee JH, Roh MR, Ko JY, Chang SE. Postinflammatory hyperpigmentation associated with treatment of solar lentigines using a Q-Switched 532-nm Nd: YAG laser: a multicenter survey. J Dermatolog Treat. 2017 Aug;28(5):447-451. doi: 10.1080/09546634.2016.1254330. Epub 2016 Nov 15.
Hwang CY, Chen CC. Serial change in laser-induced optical breakdown by 1064-nm Nd:YAG picosecond laser. Photodermatol Photoimmunol Photomed. 2020 Jan;36(1):63-64. doi: 10.1111/phpp.12505. Epub 2019 Aug 29. No abstract available.
Wang YJ, Huang YK, Wang JY, Wu YH. In vivo characterization of large cell acanthoma by cellular resolution optical coherent tomography. Photodiagnosis Photodyn Ther. 2019 Jun;26:199-202. doi: 10.1016/j.pdpdt.2019.03.020. Epub 2019 Mar 30. No abstract available.
Farhi D, Falissard B, Dupuy A. Global assessment of psoriasis severity and change from photographs: a valid and consistent method. J Invest Dermatol. 2008 Sep;128(9):2198-203. doi: 10.1038/jid.2008.68. Epub 2008 Apr 17.
Arginelli F, Greco M, Ciardo S, Josse G, Rossi AB, Le Digabel J, Questel E, Chester J, Pellacani G. Efficacy of D-pigment dermocosmetic lightening product for solar lentigo lesions of the hand: A randomized controlled trial. PLoS One. 2019 May 1;14(5):e0214714. doi: 10.1371/journal.pone.0214714. eCollection 2019.
Pandya A, Berneburg M, Ortonne JP, Picardo M. Guidelines for clinical trials in melasma. Pigmentation Disorders Academy. Br J Dermatol. 2006 Dec;156 Suppl 1:21-8. doi: 10.1111/j.1365-2133.2006.07590.x.
van Geel N, Wolkerstorfer A, Ezzedine K, Pandya AG, Bekkenk M, Grine L, Van Belle S, Lommerts JE, Hamzavi I, Harris JE, Eleftheriadou V, Esmat S, Kang HY, Kumarasinghe P, Lan CE, Parsad D, Raboobee N, Flora Xiang L, Suzuki T, Prinsen CA, Taieb A, Picardo M, Speeckaert R; participants of the Rome International VGICC /VIS Workshop. Validation of a physician global assessment tool for vitiligo extent: Results of an international vitiligo expert meeting. Pigment Cell Melanoma Res. 2019 Sep;32(5):728-733. doi: 10.1111/pcmr.12784. Epub 2019 May 9.
Other Identifiers
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2020-08-006C
Identifier Type: -
Identifier Source: org_study_id
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