Acne Scars - Mixed Atrophic and HypertrophicNCT02592993
Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars
A study testing PicoWay device in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by Syneron Medical at 3 sites in United States.
Trial summary
Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scars - Mixed Atrophic and Hypertrophic
- What is being tested?
- PicoWay device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 May 2015to Aug 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 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 acne scars and wishes to undergo laser treatments for improvement
- Have bilateral moderate to severe facial acne scars
- Willing to receive the proposed PicoWayTM fractional treatments and comply with all study (protocol) requirements
- 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
- 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
3 sites in 1 country.
United States3 sites
Dr. Eric F. Bernstein
Ardmore, Pennsylvania, 19003
Dr. Jerome M. Garden
Chicago, Illinois, 60611
New York Laser & Skin Care
New York, New York, 10028
About this study
Official title: Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Treatment of Acne Scars
Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites.
Read the detailed description
Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWayTM device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
- Being tested
- PicoWay device
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicoWay deviceDevice
The PicoWay base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier.
| Study group | Role | What they receive |
|---|---|---|
| PicoWay treatment to all subjects | Experimental | Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWay device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment. Receives: Device: PicoWay device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the PicoWayTM treatment
assessed by blinded evaluators following 3 or 5 treatments, or at 12 weeks post final treatment.
Measured: from day 0 up to 13 months
Secondary outcomes (4)
Safety of the PicoWayTM
assessed by study investigator during all study visits (treatments and follow-up).
Measured: from day 0 up to 13 months
efficacy of the PicoWayTM fractional treatment by the investigator
assessed by study investigator during all study visits (starting from the second treatment).
Measured: after 3 weeks up to 13 months
Evaluate investigator satisfaction post treatments
assessed by investigator satisfaction post treatments
Measured: after 46 weeks and after 52 weeks
subject satisfaction post treatments
assessed by subject satisfaction post treatments.
Measured: after 46 weeks and after 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start23 May 2015
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
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 Acne Scars - Mixed Atrophic and HypertrophicStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592993
- Sponsor's protocol ID
- DHF17261
- Status last verified
- Feb 2017
- First submitted
- 28 Oct 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hoang Viet M, Derreumaux P, Li MS, Roland C, Sagui C, Nguyen PH. Picosecond dissociation of amyloid fibrils with infrared laser: A nonequilibrium simulation study. J Chem Phys. 2015 Oct 21;143(15):155101. doi: 10.1063/1.4933207.
PubMed 26493925
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Treatment of Acne Scars
- ClinicalTrials.gov ID
- NCT02592993
- Acronym / sponsor ID
- DHF17261
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- 23 May 2015 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 30 Oct 2015 (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.
Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites.
Detailed description
Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWayTM device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PicoWay treatment to all subjects | Experimental | Device: PicoWay deviceSubjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWay device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy female and male subjects between 18 to 75 years of age
- Has Fitzpatrick skin type I-VI
- Subjects seeking treatment for acne scars and wishes to undergo laser treatments for improvement
- Have bilateral moderate to severe facial acne scars
- Willing to receive the proposed PicoWayTM fractional treatments and comply with all study (protocol) requirements
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
- 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 deviceThe PicoWay base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier. | Device | PicoWay treatment to all subjects |
Primary outcome
Efficacy of the PicoWayTM treatment
Time frame: from day 0 up to 13 months
assessed by blinded evaluators following 3 or 5 treatments, or at 12 weeks post final treatment.
4 secondary outcomes
Safety of the PicoWayTM
Time frame: from day 0 up to 13 months
efficacy of the PicoWayTM fractional treatment by the investigator
Time frame: after 3 weeks up to 13 months
Evaluate investigator satisfaction post treatments
Time frame: after 46 weeks and after 52 weeks
subject satisfaction post treatments
Time frame: after 46 weeks and after 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 26493925Hoang Viet M, Derreumaux P, Li MS, Roland C, Sagui C, Nguyen PH. Picosecond dissociation of amyloid fibrils with infrared laser: A nonequilibrium simulation study. J Chem Phys. 2015 Oct 21;143(15):155101. doi: 10.1063/1.4933207.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PicoWay device in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by Syneron Medical at 3 sites 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 8 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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Efficacy of the PicoWayTM treatment (time frame: from day 0 up to 13 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 NCT02592993, 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 23 Feb 2017.