Benign Pigmented LesionsNCT02146820
Picosecond Laser for Ttreatment of Benign Pigmented Lesions
A study testing GentleMax system in people with Benign Pigmented Lesions, run by Syneron Medical at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of benign pigmented lesions. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Benign Pigmented Lesions
- What is being tested?
- GentleMax system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2013to May 2015
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has Fitzpatrick skin type I-VI
- Has unwanted benign pigmented lesions including but not limited to solar lentigines, freckles, café au lait, melasma, New of Ota, Nevus of Ito, and hyperpigmentation, and wishes to undergo laser treatments to remove them
- Is willing to sign an informed consent form to participate in 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
Who cannot join
- Is hypersensitive to light exposure
- Has an active sun tan
- Has active localized or systemic infection
- Is taking medication(s) for which sunlight is a contraindication
- Has a history of squamous cell carcinoma or melanoma
- Has a history of keloid scarring
Show all 12Show fewer
- Has used 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.
- Has had a laser procedure, a peel or has used lightening creams in the area to be treated with in the past six months
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
- Is female and pregnant is currently breast feeding or planning a pregnancy during the study period
- Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Laser and Cosmetic Dermatology
San Francisco, California, 94115
About this study
Official title: LASER TREATMENT OF BENIGN PIGMENTED LESIONS WITH A DUAL WAVELENGTH PICOSECOND LASER
The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of benign pigmented lesions.
Read the detailed description
The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps.
- Conditions
- Benign Pigmented Lesions
- Being tested
- GentleMax system
- Keywords
- Pigmented Lesions, Skin Pigment, Picosecond Laser, Syneron
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentleMax systemDevice
Picosecond Laser System for the Treatment of Pigmented Lesions
| Study group | Role | What they receive |
|---|---|---|
| Picosecond Laser System | Experimental | Not described Receives: Device: GentleMax system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global percentage of pigment clearance
Global percentage of pigment clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs.
Measured: 3 months post the final treatment
Secondary outcomes (1)
Number of Participants with Adverse Events
Adverse events will be evaluated immediately after and before each subsequent laser treatment and will be based on the incidence and severity of side effects caused by the laser treatments.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shlomit Mann, Study director, Syneron Medical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146820
- Sponsor's protocol ID
- DHF13661
- Status last verified
- Jun 2015
- First submitted
- 19 May 2014
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LASER TREATMENT OF BENIGN PIGMENTED LESIONS WITH A DUAL WAVELENGTH PICOSECOND LASER
- ClinicalTrials.gov ID
- NCT02146820
- Acronym / sponsor ID
- DHF13661
- Conditions
- Benign Pigmented Lesions
- Keywords
- Pigmented Lesions, Skin Pigment, Picosecond Laser, Syneron
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- May 2015 (actual)
- First posted
- 26 May 2014 (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 purpose of this study is to determine whether Pico laser is effective and safe in the treatment of benign pigmented lesions.
Detailed description
The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Picosecond Laser System | Experimental | Device: GentleMax system |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has Fitzpatrick skin type I-VI
- Has unwanted benign pigmented lesions including but not limited to solar lentigines, freckles, café au lait, melasma, New of Ota, Nevus of Ito, and hyperpigmentation, and wishes to undergo laser treatments to remove them
- Is willing to sign an informed consent form to participate in 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
Key exclusion criteria (12 listed)
- Is hypersensitive to light exposure
- Has an active sun tan
- Has active localized or systemic infection
- Is taking medication(s) for which sunlight is a contraindication
- Has a history of squamous cell carcinoma or melanoma
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 |
|---|---|---|
| GentleMax systemPicosecond Laser System for the Treatment of Pigmented Lesions | Device | Picosecond Laser System |
Primary outcome
Global percentage of pigment clearance
Time frame: 3 months post the final treatment
Global percentage of pigment clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs.
1 secondary outcome
Number of Participants with Adverse Events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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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.
Shlomit Mann study director
Syneron Medical Ltd.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GentleMax system in people with Benign Pigmented Lesions, run by Syneron Medical at 2 sites in 2 countries.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global percentage of pigment clearance (time frame: 3 months post the final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2015.