Benign Pigmented LesionsNCT04861246
Evaluation of Laser Treatment for Benign Pigmented Lesions by Non-invasive, Cellular Resolution Optical Coherence Tomography
A study testing Laser, ApolloVue® S100 Image System and VISIA® in people with Benign Pigmented Lesions, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Benign Pigmented Lesions
- What is being tested?
- Laser, ApolloVue® S100 Image System and VISIA®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Sep 2021to 22 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Laser, ApolloVue® S100 Image System, VISIA®
- Keywords
- Optical Coherence Tomograohy, Non-invasive image system, Cellular level resolution, Full-Field OCT, Hyperpigmentation
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
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 SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Epidermal pigmented lesion Receives: Device: Laser; Device: ApolloVue® S100 Image System; Device: VISIA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 0: Extremely lighter than pigment of surrounding skin (completely depigmented)
- 1: markedly lighter than pigment of surrounding skin
- 2: moderately lighter than pigment of surrounding skin
- 3: slightly lighter than pigment of surrounding skin
- 4: equal with pigment of surrounding skin
- 5: slightly darker than pigment of surrounding skin
- 6: moderately darker than pigment of surrounding skin
- 7: markedly darker than pigment of surrounding skin
- 8: extremely darker than pigment of surrounding skin
Measured: 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.
- 0: completely cleared of undesired pigment; no evidence of cosmetic deficit remaining; 100% improvement
- 1: significant clearance of undesired pigment; slight evidence of cosmetic deficit remaining; about 75% improvement
- 2: moderate clearance of undesired pigment; moderate evidence of cosmetic deficit remaining; about 50% improvement
- 3: slight clearance of undesired pigment; marked evidence of cosmetic deficit remaining; about 25% improvement
- 4: no change in cosmetic appearance from baseline
- 5: cosmetic appearance worse than at baseline
Measured: 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.
- 0: completely cleared of undesired pigment; no evidence of cosmetic deficit remaining; 100% improvement
- 1: significant clearance of undesired pigment; slight evidence of cosmetic deficit remaining; about 75% improvement
- 2: moderate clearance of undesired pigment; moderate evidence of cosmetic deficit remaining; about 50% improvement
- 3: slight clearance of undesired pigment; marked evidence of cosmetic deficit remaining; about 25% improvement
- 4: no change in cosmetic appearance from baseline
- 5: cosmetic appearance worse than at baseline
Measured: one and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start15 Sep 2021
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Why it stopped: Slow recruitment due to covid-19 disruptions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Benign Pigmented LesionsStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Apollo Medical Optics, Ltd
- Responsible party
- Sponsor
- Investigators
- Cheng-Yuan Li, M.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861246
- Sponsor's protocol ID
- 2020-08-006C
- Status last verified
- Jul 2022
- First submitted
- 26 Apr 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vashi NA, Kundu RV. Facial hyperpigmentation: causes and treatment. Br J Dermatol. 2013 Oct;169 Suppl 3:41-56. doi: 10.1111/bjd.12536.
PubMed 24098900Vachiramon 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.
PubMed 27096729Wang 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.
PubMed 16635661Kang 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.
PubMed 27786580Hwang 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.
PubMed 31396986Wang 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.
PubMed 30940575Farhi 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.
PubMed 18418412Arginelli 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.
PubMed 31042723Pandya 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.
PubMed 17176301van 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.
PubMed 30945409
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Laser Treatment for Benign Pigmented Lesions by Non-invasive, Cellular Resolution Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT04861246
- Acronym / sponsor ID
- 2020-08-006C
- Conditions
- Benign Pigmented Lesions
- Keywords
- Optical Coherence Tomograohy, Non-invasive image system, Cellular level resolution, Full-Field OCT, Hyperpigmentation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment due to covid-19 disruptions
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Apollo Medical Optics, Ltd
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Laser, Device: ApolloVue® S100 Image System, Device: VISIA®Epidermal pigmented lesion |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaserThe 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. | Device | Experimental |
| ApolloVue® S100 Image SystemThe 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. | Device | Experimental |
| VISIA®The device is skin analysis system and will be used to obtain before and after images of laser treatment. | Device | Experimental |
Primary outcome
Static Physician's Global Assessment (PGA)
Time frame: one and a half years
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
Dynamic Physician's Global Assessment (PGA)
Time frame: one and a half years
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
Subject satisfaction
Time frame: one and a half years
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
Results and safety
The study was stopped early (reason given: Slow recruitment due to covid-19 disruptions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 24098900Vashi NA, Kundu RV. Facial hyperpigmentation: causes and treatment. Br J Dermatol. 2013 Oct;169 Suppl 3:41-56. doi: 10.1111/bjd.12536.
- Background: PubMed 27096729Vachiramon 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.
- Background: PubMed 16635661Wang 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.
- Background: PubMed 27786580Kang 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.
- Background: PubMed 31396986Hwang 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.
- Background: PubMed 30940575Wang 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.
- Background: PubMed 18418412Farhi 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.
- Background: PubMed 31042723Arginelli 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.
- Background: PubMed 17176301Pandya 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.
- Background: PubMed 30945409van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Yuan Li, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser, ApolloVue® S100 Image System and VISIA® in people with Benign Pigmented Lesions, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment due to covid-19 disruptions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Physician's Global Assessment (PGA) (time frame: one and a half years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04861246, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.