Benign Pigmented LesionsNCT02891239
785nm Picosecond Laser for Treatment of Benign Pigmented Lesions
A study testing PicoWay in people with Benign Pigmented Lesions, run by Syneron Medical at 1 site in United States.
Trial summary
This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWay device using the 785 nm wavelength alone or combined with 1064 nm or 532 nm wavelengths. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Benign Pigmented Lesions
- What is being tested?
- PicoWay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 2017
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female and male subjects between 18 to 70 years of age
- Fitzpatrick skin type I-VI
- Presence of unwanted benign pigmented lesions including but not limited to solar lentigines, freckles, café au lait, melasma, Nevis of Ota, Nevus of Ito and hyperpigmentation. Multiple lesions can be treated.
- Willing to receive the proposed PicoWay treatments and comply with all study (protocol) requirements to remove unwanted benign pigmented lesions.
- Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked).
- For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence)
- Informed consent process is completed and subject consent is signed.
Who cannot join
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
- Hypersensitivity to light exposure
- Taking medication(s) for which sunlight is a contraindication
- Active sun tan
- Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
- History of squamous cell carcinoma or melanoma
Show all 13Show fewer
- History of keloid scarring, abnormal wound healing and / or prone to bruising
- Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment, e.g., lack of noticeable skin flaking, skin peeling and skin surface roughness
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
- Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
- Has had a laser procedure, a peel or has used lightening creams in the area to be treated with in the past six months
- Subjects with pigmented lesions that are considered not acceptable by the study doctor or any condition that, in the study doctor's opinion, would make it unsafe to treat
- As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Syneron Candela Institute for Education Clinic
Wayland, Massachusetts, 01778
Meghan Murphy, BSN, 508-358-0359
Konika Schallen, MD
About this study
Official title: Clinical Study to Evaluate the Performance of the PicoWay 1064 nm/ 785 nm/ 532nm Picosecond Laser for Treatment of Benign Pigmented Lesions
This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWay device using the 785 nm wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment.
Read the detailed description
This study is a prospective clinical study to demonstrate the safety and efficacy of the PicoWay device for benign pigmented lesion treatment.
Up to a total of 60 healthy candidates, who are seeking treatment/clearance of benign pigmented lesions, will be enrolled at up to 3 participating study sites. Subjects will receive up to eight (8) PicoWay treatments at 11±5 (6-16) week's intervals. Prior to each consecutive treatment, the investigator will decide, based on degree of clearance assessment, should the subject undergo additional treatment or proceed to the 8-weeks follow-up (FU) visit with no more treatments.
- Conditions
- Benign Pigmented Lesions
- Being tested
- PicoWay
- Keywords
- laser treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicoWayDevice
Also called PicoWay device
solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm or wavelength of 785 nm that was added to the system
| Study group | Role | What they receive |
|---|---|---|
| PicoWay laser treatment | Experimental | 3 wavelength tattoo treatment with picosecond laser (PicoWay) Receives: Device: PicoWay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinded evaluation of pigmentation clearance
Global percentage of pigmentation clearance, as assessed by blinded evaluators based on comparing pre and post treatment photos.
Measured: 8 weeks post final treatment
Secondary outcomes (4)
Global percentage of pigmentation clearance
Global percentage of pigmentation clearance, as assessed by study investigators based on comparing pre and post treatment photos.
Measured: 8 weeks post final treatment
Number of patients with adverse events
Based on rate and severity of treatments with the PicoWay laser treatment
Measured: Through study completion, average of 1 year
Investigator satisfaction with treatment
A 5-point satisfaction scale will be used by study investigators to assess satisfaction with treatment outcome
Measured: 8 weeks post final treatment
Subject satisfaction with treatment
A 5-point satisfaction scale will be used by subjects to assess satisfaction with treatment outcome
Measured: 8 weeks post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Pigmented LesionsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konika Schallen, MD, Principal investigator, Syneron Candela Institute for Education Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891239
- Sponsor's protocol ID
- DHF21261
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bernstein EF, Schomacker KT, Basilavecchio LD, Plugis JM, Bhawalkar JD. A novel dual-wavelength, Nd:YAG, picosecond-domain laser safely and effectively removes multicolor tattoos. Lasers Surg Med. 2015 Sep;47(7):542-548. doi: 10.1002/lsm.22391. Epub 2015 Jul 14.
PubMed 26175187Levin 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 26922302
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of the PicoWay 1064 nm/ 785 nm/ 532nm Picosecond Laser for Treatment of Benign Pigmented Lesions
- ClinicalTrials.gov ID
- NCT02891239
- Acronym / sponsor ID
- DHF21261
- Conditions
- Benign Pigmented Lesions
- Keywords
- laser treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 7 Sep 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.
This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWay device using the 785 nm wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment.
Detailed description
This study is a prospective clinical study to demonstrate the safety and efficacy of the PicoWay device for benign pigmented lesion treatment.
Up to a total of 60 healthy candidates, who are seeking treatment/clearance of benign pigmented lesions, will be enrolled at up to 3 participating study sites. Subjects will receive up to eight (8) PicoWay treatments at 11±5 (6-16) week's intervals. Prior to each consecutive treatment, the investigator will decide, based on degree of clearance assessment, should the subject undergo additional treatment or proceed to the 8-weeks follow-up (FU) visit with no more treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PicoWay laser treatment | Experimental | Device: PicoWay3 wavelength tattoo treatment with picosecond laser (PicoWay) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy female and male subjects between 18 to 70 years of age
- Fitzpatrick skin type I-VI
- Presence of unwanted benign pigmented lesions including but not limited to solar lentigines, freckles, café au lait, melasma, Nevis of Ota, Nevus of Ito and hyperpigmentation. Multiple lesions can be treated.
- Willing to receive the proposed PicoWay treatments and comply with all study (protocol) requirements to remove unwanted benign pigmented lesions.
- Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked).
Key exclusion criteria (13 listed)
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
- Hypersensitivity to light exposure
- Taking medication(s) for which sunlight is a contraindication
- Active sun tan
- Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
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 |
|---|---|---|
| PicoWayAlso: PicoWay devicesolid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm or wavelength of 785 nm that was added to the system | Device | PicoWay laser treatment |
Primary outcome
Blinded evaluation of pigmentation clearance
Time frame: 8 weeks post final treatment
Global percentage of pigmentation clearance, as assessed by blinded evaluators based on comparing pre and post treatment photos.
4 secondary outcomes
Global percentage of pigmentation clearance
Time frame: 8 weeks post final treatment
Number of patients with adverse events
Time frame: Through study completion, average of 1 year
Investigator satisfaction with treatment
Time frame: 8 weeks post final treatment
Subject satisfaction with treatment
Time frame: 8 weeks post final treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Background: PubMed 26175187Bernstein EF, Schomacker KT, Basilavecchio LD, Plugis JM, Bhawalkar JD. A novel dual-wavelength, Nd:YAG, picosecond-domain laser safely and effectively removes multicolor tattoos. Lasers Surg Med. 2015 Sep;47(7):542-548. doi: 10.1002/lsm.22391. Epub 2015 Jul 14.
- Background: 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.
- Individual participant dataSharing planned: Undecided
Related trials for Benign Pigmented Lesions
Active, not recruiting
Pilot Evaluation of the Lutronic PicoPlus System for the Treatment of Benign Pigmented Lesions of the Hands
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.
Konika Schallen, MD principal investigator
Syneron Candela Institute for Education Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PicoWay in people with Benign Pigmented Lesions, run by Syneron Medical at 1 site in United States.
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 13 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 14 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konika Schallen, MD (508-358-7400, konikap@syneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blinded evaluation of pigmentation clearance (time frame: 8 weeks post final treatment). 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 NCT02891239, which also lists 2 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 14 Sep 2016; AzTrials last refreshed its copy on 8 Nov 2026.