Benign Pigmented LesionsPhase 4NCT02800525
Comparison of Picosecond and Q-switched Laser for Benign Pigmented Lesions Treatment
A Phase 4 study testing Picosecond laser and Q-switched Nd:YAG laser in people with Benign Pigmented Lesions, run by Mahidol University at 1 site in Thailand.
Trial summary
The objective of this study is to evaluate the efficacy and safety of picosecond 532 and 1,064 nanometers laser in the treatment of benign pigmented lesions compared with q-switched 532 and 1,064 nanometers laser. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Benign Pigmented Lesions
- What is being tested?
- Picosecond laser and Q-switched Nd:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2016to Sep 2018
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >18
- having any benign pigmented lesions on both sides of the face or any tattoo on any part of body which would like to be removed
- Fitzpatrick skin phototype 3-5
Who cannot join
- Previously treated with any laser within 3 months before enrollment into the study
- Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind
- Patients who have photosensitive dermatoses
- Pregnancy and lactation woman
- Patients with wound infections (herpes, other) on the day of treatment
- Patients with moderate and severe inflammatory acne, Immunosuppressed patients, history of vitiligo
- Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Dermatology, Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
Woraphong - Manuskiatti, Prof.,M.D, +66819150555, Doctorlaser@gmail.com
Chanida - Ungaksornpairote, M.D., +66834315359, Meisjoy@hotmail.com
About this study
Official title: The Comparison of Picosecond 532 and 1,064 Nanometers Laser and Q-switched Nd:YAG 532 and 1,064 Nanometers Laser in the Treatment of Benign Pigmented Lesions: A Randomized Controlled Trial
The objective of this study is to evaluate the efficacy and safety of picosecond 532 and 1,064 nanometers laser in the treatment of benign pigmented lesions compared with q-switched 532 and 1,064 nanometers laser.
Read the detailed description
Benign pigmented lesions can be divided into epidermal lesions such as freckles, lentigines, solar lentigines or cafe au lait macules and dermal lesions such as Nevus of Ota or Hori's nevus.
Q-switched 532 and 1064 nm lasers were reported to be safe and effective in the treatment of these benign pigmented lesions. By using selective photothermolysis theory, both q-switched 532 and 1064 nm lasers target on melanin causes photomechanical destruction of the melanin. However, the occurrence of post inflammatory hyperpigmentation (PIH) were reported especially in patients with darker skin type.
Recently, picosecond 532, 755, 1064 nm laser was reported to treat benign pigmented lesions effectively. With their ultra short pulse duration (picosecond domain), it is ideally believed to be pure photomechanical effects without thermal injury to surrounding tissue. As a result, the incident of PIH should be reduced.
The investigators then aimed to compared the efficacy and efficacy of different pulse duration between nanosecond and picosecond laser in the treatment of benign pigmented lesions.
- Conditions
- Benign Pigmented Lesions
- Being tested
- Picosecond laser, Q-switched Nd:YAG laser
- Keywords
- Benign pigmented lesions, Picosecond laser, Q-switched laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picosecond laserDevice
Picosecond 532 and 1064 nm laser Treatment of facial pigmented lesions. The energy using depends on the endpoint of immediate whitening of the lesions. The wavelength using depends on the depth of lesions.
Q-switched Nd:YAG laserDevice
Q-switched Nd-YAG 532 and 1064 nm laser. Treatment of facial pigmented lesions. The energy using depends on the endpoint of immediate whitening of the lesions. The wavelength using depends on the depth of lesion.
| Study group | Role | What they receive |
|---|---|---|
| Picosecond laser | Experimental | The pigmented lesions on this half-side of the face would be treated with picosecond laser.
For epidermal lesions, 1 laser treatment would be performed. For dermal lesions, 5 laser treatments would be performed every 3 month-interval.
The wavelength of 532 or 1064 nm would be chosen for appropriate lesions Receives: Device: Picosecond laser |
| Q-switched Nd:YAG laser | Active comparator | The pigmented lesions on this half-side of the face would be treated with q-switched Nd:YAG laser.
For epidermal lesions, 1 laser treatment would be performed. For dermal lesions, 5 laser treatments would be performed every 3 month-interval.
The wavelength of 532 or 1064 nm would be chosen for appropriate lesions Receives: Device: Q-switched Nd:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doctor evaluation of improvement using quartile scale
Quartile scale 0-4
Measured: For epidermal lesion: 1 and 3 months after 1 laser treatment. For dermal lesion: 1, 3 and 6 months after 5 laser treatments
Secondary outcomes (2)
Side effect occurrence
Measured: immediately after treatments, 2, 3, 4, and 12 weeks after the 1st laser treatment, and added more 1, 3 and 6 months after 5 laser treatments for dermal lesions
Patients evaluation of improvement using quartile scale
Measured: For epidermal lesion: 1 and 3 months after 1 laser treatment. For dermal lesion: 1, 3 and 6 months after 5 laser treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Mahidol UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woraphong Manuskiatti, M.D., Mahidol University
- Investigators
- Woraphong Manuskiatti, Prof., M.D., Principal investigator, Department of Dermatology, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800525
- Sponsor's protocol ID
- Si468/2016 (EC1)
- Status last verified
- Jun 2016
- First submitted
- 7 Jun 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Friedman DJ. Successful Treatment of a Red and Black Professional Tattoo in Skin Type VI With a Picosecond Dual-Wavelength, Neodymium-Doped Yttrium Aluminium Garnet Laser. Dermatol Surg. 2016 Sep;42(9):1121-3. doi: 10.1097/DSS.0000000000000780. No abstract available.
PubMed 27227473Levin MK, Ng E, Bae YS, Brauer JA, Geronemus RG. Treatment of pigmentary disorders in patients with skin of color with a novel 755 nm picosecond, Q-switched ruby, and Q-switched Nd:YAG nanosecond lasers: A retrospective photographic review. Lasers Surg Med. 2016 Feb;48(2):181-7. doi: 10.1002/lsm.22454.
PubMed 26922302Chan JC, Shek SY, Kono T, Yeung CK, Chan HH. A retrospective analysis on the management of pigmented lesions using a picosecond 755-nm alexandrite laser in Asians. Lasers Surg Med. 2016 Jan;48(1):23-9. doi: 10.1002/lsm.22443. Epub 2015 Dec 22.
PubMed 26696500Bogdan Allemann I, Goldberg DJ. Benign pigmented lesions. Curr Probl Dermatol. 2011;42:81-96. doi: 10.1159/000328267. Epub 2011 Aug 16.
PubMed 21865801Bukvic Mokos Z, Lipozencic J, Ceovic R, Stulhofer Buzina D, Kostovic K. Laser therapy of pigmented lesions: pro and contra. Acta Dermatovenerol Croat. 2010;18(3):185-9.
PubMed 20887701
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Picosecond 532 and 1,064 Nanometers Laser and Q-switched Nd:YAG 532 and 1,064 Nanometers Laser in the Treatment of Benign Pigmented Lesions: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02800525
- Acronym / sponsor ID
- Si468/2016 (EC1)
- Conditions
- Benign Pigmented Lesions
- Keywords
- Benign pigmented lesions, Picosecond laser, Q-switched laser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- 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.
The objective of this study is to evaluate the efficacy and safety of picosecond 532 and 1,064 nanometers laser in the treatment of benign pigmented lesions compared with q-switched 532 and 1,064 nanometers laser.
Detailed description
Benign pigmented lesions can be divided into epidermal lesions such as freckles, lentigines, solar lentigines or cafe au lait macules and dermal lesions such as Nevus of Ota or Hori's nevus.
Q-switched 532 and 1064 nm lasers were reported to be safe and effective in the treatment of these benign pigmented lesions. By using selective photothermolysis theory, both q-switched 532 and 1064 nm lasers target on melanin causes photomechanical destruction of the melanin. However, the occurrence of post inflammatory hyperpigmentation (PIH) were reported especially in patients with darker skin type.
Recently, picosecond 532, 755, 1064 nm laser was reported to treat benign pigmented lesions effectively. With their ultra short pulse duration (picosecond domain), it is ideally believed to be pure photomechanical effects without thermal injury to surrounding tissue. As a result, the incident of PIH should be reduced.
The investigators then aimed to compared the efficacy and efficacy of different pulse duration between nanosecond and picosecond laser in the treatment of benign pigmented lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Picosecond laser | Experimental | Device: Picosecond laserThe pigmented lesions on this half-side of the face would be treated with picosecond laser. For epidermal lesions, 1 laser treatment would be performed. For dermal lesions, 5 laser treatments would be performed every 3 month-interval. The wavelength of 532 or 1064 nm would be chosen for appropriate lesions |
| Q-switched Nd:YAG laser | Active comparator | Device: Q-switched Nd:YAG laserThe pigmented lesions on this half-side of the face would be treated with q-switched Nd:YAG laser. For epidermal lesions, 1 laser treatment would be performed. For dermal lesions, 5 laser treatments would be performed every 3 month-interval. The wavelength of 532 or 1064 nm would be chosen for appropriate lesions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age >18
- having any benign pigmented lesions on both sides of the face or any tattoo on any part of body which would like to be removed
- Fitzpatrick skin phototype 3-5
Key exclusion criteria (7 listed)
- Previously treated with any laser within 3 months before enrollment into the study
- Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind
- Patients who have photosensitive dermatoses
- Pregnancy and lactation woman
- Patients with wound infections (herpes, other) on the day of treatment
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 |
|---|---|---|
| Picosecond laserPicosecond 532 and 1064 nm laser Treatment of facial pigmented lesions. The energy using depends on the endpoint of immediate whitening of the lesions. The wavelength using depends on the depth of lesions. | Device | Picosecond laser |
| Q-switched Nd:YAG laserQ-switched Nd-YAG 532 and 1064 nm laser. Treatment of facial pigmented lesions. The energy using depends on the endpoint of immediate whitening of the lesions. The wavelength using depends on the depth of lesion. | Device | Q-switched Nd:YAG laser |
Primary outcome
Doctor evaluation of improvement using quartile scale
Time frame: For epidermal lesion: 1 and 3 months after 1 laser treatment. For dermal lesion: 1, 3 and 6 months after 5 laser treatments
Quartile scale 0-4
2 secondary outcomes
Side effect occurrence
Time frame: immediately after treatments, 2, 3, 4, and 12 weeks after the 1st laser treatment, and added more 1, 3 and 6 months after 5 laser treatments for dermal lesions
Patients evaluation of improvement using quartile scale
Time frame: For epidermal lesion: 1 and 3 months after 1 laser treatment. For dermal lesion: 1, 3 and 6 months after 5 laser treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Results publication: PubMed 27227473Friedman DJ. Successful Treatment of a Red and Black Professional Tattoo in Skin Type VI With a Picosecond Dual-Wavelength, Neodymium-Doped Yttrium Aluminium Garnet Laser. Dermatol Surg. 2016 Sep;42(9):1121-3. doi: 10.1097/DSS.0000000000000780. No abstract available.
- Results publication: PubMed 26922302Levin MK, Ng E, Bae YS, Brauer JA, Geronemus RG. Treatment of pigmentary disorders in patients with skin of color with a novel 755 nm picosecond, Q-switched ruby, and Q-switched Nd:YAG nanosecond lasers: A retrospective photographic review. Lasers Surg Med. 2016 Feb;48(2):181-7. doi: 10.1002/lsm.22454.
- Results publication: PubMed 26696500Chan JC, Shek SY, Kono T, Yeung CK, Chan HH. A retrospective analysis on the management of pigmented lesions using a picosecond 755-nm alexandrite laser in Asians. Lasers Surg Med. 2016 Jan;48(1):23-9. doi: 10.1002/lsm.22443. Epub 2015 Dec 22.
- Results publication: PubMed 21865801Bogdan Allemann I, Goldberg DJ. Benign pigmented lesions. Curr Probl Dermatol. 2011;42:81-96. doi: 10.1159/000328267. Epub 2011 Aug 16.
- Results publication: PubMed 20887701Bukvic Mokos Z, Lipozencic J, Ceovic R, Stulhofer Buzina D, Kostovic K. Laser therapy of pigmented lesions: pro and contra. Acta Dermatovenerol Croat. 2010;18(3):185-9.
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Benign Pigmented Lesions
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.
Woraphong Manuskiatti, Prof., M.D. principal investigator
Department of Dermatology, Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Picosecond laser and Q-switched Nd:YAG laser in people with Benign Pigmented Lesions, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Sep 2016. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woraphong Manuskiatti, Prof., M.D. (66-2419-9922, siwmn@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doctor evaluation of improvement using quartile scale (time frame: For epidermal lesion: 1 and 3 months after 1 laser treatment. For dermal lesion: 1, 3 and 6 months after 5 laser treatments). 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 NCT02800525, which also lists 5 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 20 Sep 2016.