DyschromiaNCT02700204
Histological Study to Evaluate Skin Changes After PicoWay® 1064 nm and 532nm Picosecond Fractional Laser Treatment
A study testing PicoWay 532nm fractional treatment and PicoWay 1064nm fractional treatment in people with Dyschromia, run by Syneron Medical at 1 site in United States.
Trial summary
This is an open-label, two-arm, histological evaluation study. Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to receive PicoWay fractional treatment: Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece Subjects will receive one treatment for peri auricular and/or Buttocks… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyschromia
- What is being tested?
- PicoWay 532nm fractional treatment and PicoWay 1064nm fractional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female and male subjects between 18 to 75 years of age
- Has Fitzpatrick skin type I-VI
- Subjects seeking treatment for having blemished skin, where the blemishes are of the type that photo rejuvenation would be a potential treatment option, including dyschromia, acne scars, wrinkles, etc., and willing to undergo laser treatment and skin biopsies pre-treatment, immediately after treatment, and at the 2-month follow-up
- Willing to receive the proposed PicoWay fractional treatments and comply with all study (protocol) requirements including consenting to a minimum of 5 biopsies: at least 1 biopsy pretreatment, at least 2 biopsies immediately after treatment (at least 1 from each side), or at least 2 biopsies at 48 hours after treatment (at least 1 from each side) and at least 2 biopsies at 2 months after treatment (at least 1 from each side)
- 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
- Active sun tan in facial area for patient who will treat peri-auricular area.
- 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
- Is taking medication(s) for which sunlight is a contraindication
- Has a history of squamous cell carcinoma or melanoma
Show all 14Show fewer
- History of keloid scarring, abnormal wound healing and / or prone to bruising
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
- 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.
- A laser procedure, a peel or has used lightening creams that was performed in the area to be treated with the past six months
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
- Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
- Subjects with pigmented lesions that are considered not acceptable by the study investigator or any condition that, in the investigator'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.
About this study
This is an open-label, two-arm, histological evaluation study.
Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to receive PicoWay fractional treatment:
Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece Subjects will receive one treatment for peri auricular and/or Buttocks according the Investigator decision, with the fractional hand-piece
All subjects will have biopsies from the treated area:
- at baseline prior to treatment;
- immediately after treatment (within 30 minutes) or 48 hours after treatment;
- 2 months after treatment. Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
Read the detailed description
This histological study is a prospective clinical study to evaluate skin biopsies after a single PicoWay treatment with the 532nm or 1064nm fractional hand-piece.
Up to 30 healthy candidates, will be enrolled at up to 2 participating study sites. Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to receive fractional treatment for peri auricular and/or Buttocks according to investigator decision:
Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece
Subjects will receive one treatment for peri auricular and/or Buttocks, with the fractional hand-piece. The investigator may use a multiplicity of energy levels in area or subarea in a single treatment, in order to titrate the optimum energy level. Further, if the investigator elects to, the Picoway handpiece can have at its distal end (at the distance gauge ending) a flat piece of a transparent plastic/glass (with appropriate anti reflective coating if desired), which will be in contact with the skin. In this case, the investigator may also elect to use a coupling gel as a matching medium between the skin and the glass.
All subjects will have biopsies of the treated area (a single or two peri or post-auricular, buttocks) at baseline prior to treatment. Biopsies from each area will also be performed immediately after treatment (within 30 minutes) and/or at ~48 hours after treatment, according to physician discretion, and at the 2-month follow-up.
Topical anesthetic (ointment) or intradermal injected solution may be used prior to treatment
- Conditions
- Dyschromia
- Being tested
- PicoWay 532nm fractional treatment, PicoWay 1064nm fractional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicoWay 532nm fractional treatmentDevice
Also called PicoWay Resolve 532nm handpiece
is a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps
PicoWay 1064nm fractional treatmentDevice
Also called PicoWay Resolve 1064nm handpiece
is a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps
| Study group | Role | What they receive |
|---|---|---|
| PicoWay 532nm fractional treatment | Experimental | subjects will receive one treatment for peri auricular and/or Buttocks by 532nm hand-piece Receives: Device: PicoWay 532nm fractional treatment |
| PicoWay 1064nm fractional treatment | Experimental | subjects will receive one treatment for peri auricular and/or Buttocks by 1064nm hand-piece Receives: Device: PicoWay 1064nm fractional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect skin biopsies after fractional PicoWay treatments
To collect skin biopsies after fractional PicoWay treatments to evaluate depth and damage caused by laser induced optical breakdown (LIOB)
Measured: day 0 up to 2 months
Secondary outcomes (5)
Histological evidence of LIOBs and location of LIOBs
Histological evidence of LIOBs and location of LIOBs (epidermis or dermis) immediately after treatment or at 48 hours after treatment, with either the 1064nm or 532nm picosecond fractional laser focused at the surface or sub-surface of the peri auricular and/or Buttocks area/s
Measured: day 0 and at 48 hours
Observation of erythema/edema after treatment
Observation of erythema/edema after treatment via clinical skin assessment
Measured: day 0 up to 2 months
Histological evidence of an inflammatory response
Histological evidence of an inflammatory response in the dermis immediately after treatment or at 48 hours after treatment that should lead to production of new collagen and elastin
Measured: at 48 hours
Histological evidence of new collagen growth
Histological evidence of new collagen growth at 2 months after treatment with either a 1064nm or 532nm picosecond fractional laser treatment
Measured: at 2 months
Number of subjects with adverse events
The number, description, severity, intervention and outcome of any adverse events will be reported on adverse event forms
Measured: day 0, up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyschromiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arielle Kauvar, MD, Principal investigator, NY Laser Skin Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700204
- Sponsor's protocol ID
- DHF19921
- Status last verified
- Sep 2016
- First submitted
- 28 Feb 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Brightman L, Goldman MP, Taub AF. Sublative rejuvenation: experience with a new fractional radiofrequency system for skin rejuvenation and repair. J Drugs Dermatol. 2009 Nov;8(11 Suppl):s9-13.
PubMed 19916261
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Study to Evaluate Skin Changes After PicoWay® 1064 nm and 532nm Picosecond Fractional Laser Treatment
- ClinicalTrials.gov ID
- NCT02700204
- Acronym / sponsor ID
- DHF19921
- Conditions
- Dyschromia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Mar 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, two-arm, histological evaluation study.
Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to receive PicoWay fractional treatment:
Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece Subjects will receive one treatment for peri auricular and/or Buttocks according the Investigator decision, with the fractional hand-piece
All subjects will have biopsies from the treated area:
- at baseline prior to treatment;
- immediately after treatment (within 30 minutes) or 48 hours after treatment;
- 2 months after treatment. Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
Detailed description
This histological study is a prospective clinical study to evaluate skin biopsies after a single PicoWay treatment with the 532nm or 1064nm fractional hand-piece.
Up to 30 healthy candidates, will be enrolled at up to 2 participating study sites. Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to receive fractional treatment for peri auricular and/or Buttocks according to investigator decision:
Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece
Subjects will receive one treatment for peri auricular and/or Buttocks, with the fractional hand-piece. The investigator may use a multiplicity of energy levels in area or subarea in a single treatment, in order to titrate the optimum energy level. Further, if the investigator elects to, the Picoway handpiece can have at its distal end (at the distance gauge ending) a flat piece of a transparent plastic/glass (with appropriate anti reflective coating if desired), which will be in contact with the skin. In this case, the investigator may also elect to use a coupling gel as a matching medium between the skin and the glass.
All subjects will have biopsies of the treated area (a single or two peri or post-auricular, buttocks) at baseline prior to treatment. Biopsies from each area will also be performed immediately after treatment (within 30 minutes) and/or at ~48 hours after treatment, according to physician discretion, and at the 2-month follow-up.
Topical anesthetic (ointment) or intradermal injected solution may be used prior to treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PicoWay 532nm fractional treatment | Experimental | Device: PicoWay 532nm fractional treatmentsubjects will receive one treatment for peri auricular and/or Buttocks by 532nm hand-piece |
| PicoWay 1064nm fractional treatment | Experimental | Device: PicoWay 1064nm fractional treatmentsubjects will receive one treatment for peri auricular and/or Buttocks by 1064nm hand-piece |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy female and male subjects between 18 to 75 years of age
- Has Fitzpatrick skin type I-VI
- Subjects seeking treatment for having blemished skin, where the blemishes are of the type that photo rejuvenation would be a potential treatment option, including dyschromia, acne scars, wrinkles, etc., and willing to undergo laser treatment and skin biopsies pre-treatment, immediately after treatment, and at the 2-month follow-up
- Willing to receive the proposed PicoWay fractional treatments and comply with all study (protocol) requirements including consenting to a minimum of 5 biopsies: at least 1 biopsy pretreatment, at least 2 biopsies immediately after treatment (at least 1 from each side), or at least 2 biopsies at 48 hours after treatment (at least 1 from each side) and at least 2 biopsies at 2 months after treatment (at least 1 from each side)
- 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 (14 listed)
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
- Hypersensitivity to light exposure
- Active sun tan in facial area for patient who will treat peri-auricular area.
- 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
- Is taking medication(s) for which sunlight is a contraindication
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 |
|---|---|---|
| PicoWay 532nm fractional treatmentAlso: PicoWay Resolve 532nm handpieceis a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps | Device | PicoWay 532nm fractional treatment |
| PicoWay 1064nm fractional treatmentAlso: PicoWay Resolve 1064nm handpieceis a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps | Device | PicoWay 1064nm fractional treatment |
Primary outcome
To collect skin biopsies after fractional PicoWay treatments
Time frame: day 0 up to 2 months
To collect skin biopsies after fractional PicoWay treatments to evaluate depth and damage caused by laser induced optical breakdown (LIOB)
5 secondary outcomes
Histological evidence of LIOBs and location of LIOBs
Time frame: day 0 and at 48 hours
Observation of erythema/edema after treatment
Time frame: day 0 up to 2 months
Histological evidence of an inflammatory response
Time frame: at 48 hours
Histological evidence of new collagen growth
Time frame: at 2 months
Number of subjects with adverse events
Time frame: day 0, up to 7 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 2 Sep 2016.
- Background: PubMed 19916261Brightman L, Goldman MP, Taub AF. Sublative rejuvenation: experience with a new fractional radiofrequency system for skin rejuvenation and repair. J Drugs Dermatol. 2009 Nov;8(11 Suppl):s9-13.
- Individual participant dataSharing planned: Undecided
Related trials for Dyschromia
Active, not recruiting
A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing
Skin Resurfacing
RecruitingObservational study
Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia
Dental Diseases
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.
Arielle Kauvar, MD principal investigator
NY Laser Skin Care
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 532nm fractional treatment and PicoWay 1064nm fractional treatment in people with Dyschromia, 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 14 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 2 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?
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?
To collect skin biopsies after fractional PicoWay treatments (time frame: day 0 up to 2 months). 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 NCT02700204, which also lists 1 linked publication.
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 2 Sep 2016.