NCT04861246|TerminatedDMC
Study Stopped
Slow recruitment due to covid-19 disruptions
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Sponsor study identifier
interventional
10
1 country
1
Study Start
September 15, 2021
Actual (reported)Primary Completion
March 22, 2022
Actual (reported)Study Completion
March 22, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 22, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 26, 2021
Actual (reported)April 27, 2021
Actual (reported)September 15, 2021
Actual (reported)March 22, 2022
Actual (reported)March 22, 2022
Actual (reported)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. 1. 0: Extremely lighter than pigment of surrounding skin (completely depigmented) 2. 1: markedly lighter than pigment of surrounding skin 3. 2: moderately lighter than pigment of surrounding skin 4. 3: slightly lighter than pigment of surrounding skin 5. 4: equal with pigment of surrounding skin 6. 5: slightly darker than pigment of surrounding skin 7. 6: moderately darker than pigment of surrounding skin 8. 7: markedly darker than pigment of surrounding skin 9. 8: extremely darker than pigment of surrounding skin
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. 1. 0: completely cleared of undesired pigment; no evidence of cosmetic deficit remaining; 100% improvement 2. 1: significant clearance of undesired pigment; slight evidence of cosmetic deficit remaining; about 75% improvement 3. 2: moderate clearance of undesired pigment; moderate evidence of cosmetic deficit remaining; about 50% improvement 4. 3: slight clearance of undesired pigment; marked evidence of cosmetic deficit remaining; about 25% improvement 5. 4: no change in cosmetic appearance from baseline 6. 5: cosmetic appearance worse than at baseline
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. 1. 0: completely cleared of undesired pigment; no evidence of cosmetic deficit remaining; 100% improvement 2. 1: significant clearance of undesired pigment; slight evidence of cosmetic deficit remaining; about 75% improvement 3. 2: moderate clearance of undesired pigment; moderate evidence of cosmetic deficit remaining; about 50% improvement 4. 3: slight clearance of undesired pigment; marked evidence of cosmetic deficit remaining; about 25% improvement 5. 4: no change in cosmetic appearance from baseline 6. 5: cosmetic appearance worse than at baseline
Epidermal pigmented lesion
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.
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.
Taipei Veterans General Hospital
Taipei, Beitou District, 11217, Taiwan
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.
Cheng-Yuan Li, M.D.
Taipei Veterans General Hospital, Taiwan
10 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2021
First Posted
April 27, 2021
Study Start
September 15, 2021
Actual (reported)Photoaging Reversing After Picosecond Laser With DLA Assessed by Cellular Resolution OCT in Asian Patient With Melasma
one and a half years
The device is skin analysis system and will be used to obtain before and after images of laser treatment.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
March 22, 2022
Actual (reported)Study Completion
March 22, 2022
Actual (reported)Last Updated
July 21, 2022
Record last verified: 2022-07
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