Evaluation of Laser Treatment for Benign Pigmented Lesions by Non-invasive, Cellular Resolution Optical Coherence Tomography

NCT04861246 | Terminated DMC

• 1 other identifier: 2020-08-006C
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Pigmented Lesions

Keywords

Optical Coherence Tomograohy; Non-invasive image system; Cellular level resolution; Full-Field OCT; Hyperpigmentation

Outcome Measures

Primary Outcomes (3)

• 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

  one and a half years

Study Arms (1)

Experimental

EXPERIMENTAL

Epidermal pigmented lesion

Device: Laser; Device: ApolloVue® S100 Image System; Device: VISIA®

Interventions

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.

Experimental

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.

Experimental

VISIA® DEVICE

The device is skin analysis system and will be used to obtain before and after images of laser treatment.

Experimental

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Apollo Medical Optics, Ltd: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

Location

Related Publications (10)

• Vashi NA, Kundu RV. Facial hyperpigmentation: causes and treatment. Br J Dermatol. 2013 Oct;169 Suppl 3:41-56. doi: 10.1111/bjd.12536.

  PMID: 24098900 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.

  PMID: 27096729 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.

  PMID: 16635661 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.

  PMID: 27786580 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.

  PMID: 31396986 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.

  PMID: 30940575 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.

  PMID: 18418412 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.

  PMID: 31042723 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.

  PMID: 17176301 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.

  PMID: 30945409 BACKGROUND

MeSH Terms

Conditions

Hyperpigmentation

Interventions

Lasers

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Cheng-Yuan Li, M.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 27, 2021
• Study Start: September 15, 2021
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)