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Slow recruitment due to covid-19 disruptions
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| Name | Class |
|---|---|
| Apollo Medical Optics, Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Epidermal pigmented lesion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Static Physician's Global Assessment (PGA) | Static PGA is often used to evaluate disease severity of psoriasis. In recent years, this evaluation index has also been applied to pigmented diseases, such as solar lentigo, melasma, and vitiligo. In this trial, Static PGA divides the severity of pigmented diseases into 0~8.
| one and a half years |
| Dynamic Physician's Global Assessment (PGA) | Dynamic PGA is often used to evaluate the degree of improvement after treatment of the disease. In this trial, Dynamic PGA evaluates the degree of improvement after comparing with the state before treatment (baseline). The degree of improvement is divided into 0~5.
| one and a half years |
| Subject satisfaction | During the two follow-up visits after treatment, subjects will evaluate their satisfaction after treatment. In this trial, this evaluation form will be divided into 0 to 5 points according to the degree of improvement.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheng-Yuan Li, M.D. | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Beitou District | 11217 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24098900 | Background | Vashi NA, Kundu RV. Facial hyperpigmentation: causes and treatment. Br J Dermatol. 2013 Oct;169 Suppl 3:41-56. doi: 10.1111/bjd.12536. | |
| 27096729 | Background | 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. |
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| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| ApolloVue® S100 Image System | Device | 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® | Device | The device is skin analysis system and will be used to obtain before and after images of laser treatment. |
|
| one and a half years |
| 16635661 | Background | 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. |
| 27786580 | Background | 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. |
| 31396986 | Background | 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. |
| 30940575 | Background | 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. |
| 18418412 | Background | 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. |
| 31042723 | Background | 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. |
| 17176301 | Background | 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. |
| 30945409 | Background | 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. |