Benign Pigmented LesionsNCT03774849
PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles
A study testing PicoWay™ 532nm fractional handpiece, PicoWay™ 730nm wavelength and PicoWay™ 1064nm fractional handpiece in people with Benign Pigmented Lesions and Facial Wrinkles, run by Candela Corporation at 1 site in United States.
Trial summary
Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Benign Pigmented Lesions, Facial Wrinkles
- What is being tested?
- PicoWay™ 532nm fractional handpiece, PicoWay™ 730nm wavelength and PicoWay™ 1064nm fractional handpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 12 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide signed informed consent
- Adults age 21 to 80
- Fitzpatrick Skin Type (FST) I to VI
- Presence of benign pigmented Lesions assessed at baseline as Pigment Severity Score (PSS) of "2" or higher and/or wrinkles assessed at baseline as Fitzpatrick Wrinkle Score (FWS) of "2" or higher
- Willing to allow photographs and/or video to be taken of treated areas for the purposes of this research study
- Willing to abstain from any other procedures for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including surgery, light, laser, ultrasound or radiofrequency treatments
- Willing to abstain from use of prescription cosmetic products for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including injections of neurotoxins or dermal fillers, skin lightening creams, and wrinkle creams
- Willingness to adhere to study treatment and follow-up visit schedules
Who cannot join
- Pregnant, planning pregnancy or breast feeding
- Allergy to topical or injectable lidocaine or similar medications
- Allergy to topical steroid or similar medications
- Unprotected sun exposure in the six weeks prior to enrollment, or active tan in the laser treatment area
- History of melanoma in the intended treatment area
- History of keloid or hypertrophic scar formation
Show all 14Show fewer
- Use of topical or systemic retinoid therapy during the past six (6) months
- Use of neurotoxins in the intended treatment area within the past three (3) months or throughout the duration of the study
- Use of dermal fillers in the intended treatment area within the last six (6) months or throughout the duration of the study
- Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment.
- Open wound or infection in the intended treatment area
- History of light induced seizure disorders
- Dermatologic and/or cosmetic procedures in the intended treatment area(s) during the past six months
- The subject is not suitable, in the opinion of the clinician, for participation in the study due to medical or other reasons that could compromise the study integrity or subject safety
Trial locations and contacts
1 site in 1 country.
United States1 site
Syneron Candela Institute for Excellence
Wayland, Massachusetts, 01778
About this study
Official title: Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles
Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles.
Read the detailed description
Subjects will receive up to 4 study treatments with the PicoWay™ 730 nm laser wavelength, PicoWay™1064nm fractional handpiece and/or PicoWay™ 1064nm fractional handpiece for treatment of benign pigmented lesions or wrinkles. Subjects will return for three follow-up visit evaluations 1-month, 2-months and 3-months post final study treatment. Primary efficacy assessed by masked photographic evaluation. Optional biopsy collection for histological analysis of laser tissue effects.
- Conditions
- Benign Pigmented Lesions, Facial Wrinkles
- Being tested
- PicoWay™ 532nm fractional handpiece, PicoWay™ 730nm wavelength, PicoWay™ 1064nm fractional handpiece
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicoWay™ 532nm fractional handpieceDevice
PicoWay™ Laser System is picosecond 532/1064/785 laser
PicoWay™ 730nm wavelengthDevice
PicoWay™ Laser System is picosecond 532/1064/785 laser
PicoWay™ 1064nm fractional handpieceDevice
PicoWay™ Laser System is picosecond 532/1064/785 laser
| Study group | Role | What they receive |
|---|---|---|
| Picoway™ 532nm fractional handpiece | Experimental | Subjects will receive up to four study treatments with the PicoWay™ 532nm fractional handpiece Receives: Device: PicoWay™ 730nm wavelength |
| PicoWay™ 730nm wavelength | Experimental | PicoWay™ 730nm wavelength. Subjects will receive up to four study treatments with the PicoWay™ 730nm wavelength. Receives: Device: PicoWay™ 532nm fractional handpiece |
| PicoWay ™1064nm fractional handpiece | Experimental | Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece Receives: Device: PicoWay™ 1064nm fractional handpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale
9-Point Fitzpatrick Wrinkle Scale (FWS)
1=Fine Wrinkles to 9=Deep Wrinkles 1-3 Mild (fine textural changes with subtly accentuated skin lines) 4-6 Moderate (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia) 7-9 Severe (multipapular and confluent elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis)
Measured: Baseline to 12-week follow-Up Visit
Change in Benign Pigmented Lesions From Baseline to 12 Weeks Post-study Treatment in Pigment Clearance Score (PCS) as Determined by Blinded Evaluators From Clinical Photography
5-Point Pigment Clearance Score (Score, Clearance %, Description)
- = 0-24% = Poor Response
- = 25-49% = Fair Response
- = 50-74% = Good Response
- = 75-94% = Excellent Response
- = >95% = CompleteResponse
Measured: Baseline to 12-week follow-Up Visit
Secondary outcomes (1)
Change in Subject Satisfaction Mean of Scores From 2nd Treatment Visit to Last Visit by Treatment Group Using a 5-Point Likert-type Rating Scale
During the 2nd Treatment Visit and all subsequent study visits (treatment and follow-up), Subject Satisfaction Surveys were obtained from all subjects. The scale used to evaluate subject satisfaction is a Likert-type rating Scale and follows -2, -1, 0, 1, 2 for responses of Extremely Dissatisfied, Somewhat Dissatisfied, Neither Satisfied nor Dissatisfied, Somewhat Satisfied and Extremely Satisfied respectfully. The scores are stratified according to treatment group.
Measured: Pre-Treatment 2 at Week 6, Pre-Treatment 3 at Week 12, Pre-Treatment 4 at Week 18, 1 Month Follow-Up at Week 22, 2 Month Follow-Up at Week 26, and 3 Month Follow-Up at Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start5 Dec 2018
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Lowery, Study director, Director of Clinical Affairs, Candela Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774849
- Sponsor's protocol ID
- PWY18010
- Status last verified
- Nov 2023
- First submitted
- 11 Dec 2018
- Last updated
- 1 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles
- ClinicalTrials.gov ID
- NCT03774849
- Acronym / sponsor ID
- PWY18010
- Conditions
- Benign Pigmented Lesions, Facial Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Posted 1 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles.
Detailed description
Subjects will receive up to 4 study treatments with the PicoWay™ 730 nm laser wavelength, PicoWay™1064nm fractional handpiece and/or PicoWay™ 1064nm fractional handpiece for treatment of benign pigmented lesions or wrinkles. Subjects will return for three follow-up visit evaluations 1-month, 2-months and 3-months post final study treatment. Primary efficacy assessed by masked photographic evaluation. Optional biopsy collection for histological analysis of laser tissue effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Picoway™ 532nm fractional handpiece | Experimental | Device: PicoWay™ 730nm wavelengthSubjects will receive up to four study treatments with the PicoWay™ 532nm fractional handpiece |
| PicoWay™ 730nm wavelength | Experimental | Device: PicoWay™ 532nm fractional handpiecePicoWay™ 730nm wavelength. Subjects will receive up to four study treatments with the PicoWay™ 730nm wavelength. |
| PicoWay ™1064nm fractional handpiece | Experimental | Device: PicoWay™ 1064nm fractional handpieceSubjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing to provide signed informed consent
- Adults age 21 to 80
- Fitzpatrick Skin Type (FST) I to VI
- Presence of benign pigmented Lesions assessed at baseline as Pigment Severity Score (PSS) of "2" or higher and/or wrinkles assessed at baseline as Fitzpatrick Wrinkle Score (FWS) of "2" or higher
- Willing to allow photographs and/or video to be taken of treated areas for the purposes of this research study
Key exclusion criteria (14 listed)
- Pregnant, planning pregnancy or breast feeding
- Allergy to topical or injectable lidocaine or similar medications
- Allergy to topical steroid or similar medications
- Unprotected sun exposure in the six weeks prior to enrollment, or active tan in the laser treatment area
- History of melanoma in the intended treatment area
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 handpiecePicoWay™ Laser System is picosecond 532/1064/785 laser | Device | PicoWay™ 730nm wavelength |
| PicoWay™ 730nm wavelengthPicoWay™ Laser System is picosecond 532/1064/785 laser | Device | Picoway™ 532nm fractional handpiece |
| PicoWay™ 1064nm fractional handpiecePicoWay™ Laser System is picosecond 532/1064/785 laser | Device | PicoWay ™1064nm fractional handpiece |
Primary outcome
Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale
Time frame: Baseline to 12-week follow-Up Visit
9-Point Fitzpatrick Wrinkle Scale (FWS) 1=Fine Wrinkles to 9=Deep Wrinkles 1-3 Mild (fine textural changes with subtly accentuated skin lines) 4-6 Moderate (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia) 7-9 Severe (multipapular and confluent elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis)
Change in Benign Pigmented Lesions From Baseline to 12 Weeks Post-study Treatment in Pigment Clearance Score (PCS) as Determined by Blinded Evaluators From Clinical Photography
Time frame: Baseline to 12-week follow-Up Visit
5-Point Pigment Clearance Score (Score, Clearance %, Description) 1. = 0-24% = Poor Response 2. = 25-49% = Fair Response 3. = 50-74% = Good Response 4. = 75-94% = Excellent Response 5. = >95% = CompleteResponse
1 secondary outcome
Change in Subject Satisfaction Mean of Scores From 2nd Treatment Visit to Last Visit by Treatment Group Using a 5-Point Likert-type Rating Scale
Time frame: Pre-Treatment 2 at Week 6, Pre-Treatment 3 at Week 12, Pre-Treatment 4 at Week 18, 1 Month Follow-Up at Week 22, 2 Month Follow-Up at Week 26, and 3 Month Follow-Up at Week 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Joseph Lowery study director
Director of Clinical Affairs, Candela Corporation
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 handpiece, PicoWay™ 730nm wavelength and PicoWay™ 1064nm fractional handpiece in people with Benign Pigmented Lesions and Facial Wrinkles, run by Candela Corporation 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 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: finished, as of the sponsor's last update on 1 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale (time frame: Baseline to 12-week follow-Up Visit). The study lists 2 primary outcomes in all. 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 1 Dec 2023.