WrinkleNCT04727099
Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™
A study testing PicoWay Laser System in people with Wrinkle and Pigmented Lesions, run by Candela Corporation at 1 site in United States.
Trial summary
This study is intended to demonstrate the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Pigmented Lesions
- What is being tested?
- PicoWay Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 31 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age or older
- Willingness to provide signed, informed consent to participate in the study
- Presence of mild or greater benign pigmented lesions, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) >/= 1.
- Willingness to adhere to study treatment and follow-up schedule
- Willingness to adhere to post-treatment care instructions
- Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
- Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study
Who cannot join
- Pregnant, planning pregnancy during the study, or breast feeding
- Tattooed skin in the intended treatment area unless tattoo removal treatment is to be performed.
- Active sun tan in the intended treatment area
- History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
- History of melanoma
- History of vitiligo in the intended treatment area
Show all 14Show fewer
- History of keloid or hypertrophic scar formation
- History of Melasma in the intended treatment area per Investigator's discretion
- Use of systemic retinoid therapy (e.g. Accutane) during the past 6 months
- 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
- The subject is not suitable, in the opinion of the Investigator, for participation in the study due to inability to adhere to the study requirements, medical, or other reasons that could compromise the study integrity or subject safety
- Dermatologic and/or cosmetic procedures including use of medications, or topicals in the intended treatment area(s) during a timepoint prior to the study that the investigator deems the subject unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Candela Institute of Excellence
Marlborough, Massachusetts, 01752
About this study
This study is intended to demonstrate the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles.
Read the detailed description
This is a prospective, non-randomized, open-label study evaluating the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles.
Up to 200 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to 6 treatments to the face and/or off-face locations with treatment intervals of 4 weeks +/- 2 weeks. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final treatment. Total study duration is approximately 12 months (up to 9 months for treatment and 3 months for follow up).
- Conditions
- Wrinkle, Pigmented Lesions
- Being tested
- PicoWay Laser System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicoWay Laser SystemDevice
The PicoWay® laser system is an alexandrite laser pumped, solid-state Neodymium:Yttruium Aluminum Garnet (Nd:YAG) laser emitting energy at user selectable wavelengths of 1064 nm, 532 nm, 785 nm or 730 nm, designed for the treatment of tattoo, benign pigmented lesions, acne scars, and wrinkles.
| Study group | Role | What they receive |
|---|---|---|
| Benign Pigmented Lesions | Experimental | Up to six (6) treatments with PicoWay laser for treatment of benign pigmented lesions Receives: Device: PicoWay Laser System |
| Wrinkles | Experimental | Up to six (6) treatments with PicoWay laser for treatment of wrinkles Receives: Device: PicoWay Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benign Pigmented Lesions (BPLs) and Global Aesthetic Improvement Score (GAIS)
Improvement in Benign Pigmented Lesions (BPLs) from Baseline to 3 Month follow-up (= 12 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = "worse," and 1 = "very much improved."
Measured: 12 months
Benign Pigmented Lesions (BPLs) and Pigment Improvement Score (PIS)
Improvement in Benign Pigmented Lesions (BPLs) from Baseline to 3 Month follow-up (= 12 months maximum) via the Pigment Improvement Score (PIS) where a score of 0 = "no improvement" and a score of 4 = "Excellent response: Most or all lesions much lighter or gone"
Measured: 12 months
Wrinkles and Global Aesthetic Improvement Score (GAIS) 3 month follow up
Improvement in the appearance of wrinkles from Baseline 3 Month follow-up (= 12 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = "worse," and 1 = "very much improved."
Measured: 12 months
Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 3 month follow up
Improvement in the appearance of wrinkles from Baseline 3 Month follow-up (= 12 months maximum) via the Investigator Fitzpatrick Wrinkle and Elastosis Scale where a score of 1 = "fine wrinkles or mild elastosis" and 9 = "deep wrinkles or severe elastosis".
Measured: 12 months
Secondary outcomes (5)
BPLs and Global Aesthetic Improvement Score (GAIS) 1 month follow up
Improvement in BPLs from Baseline to 1 Month follow-up (= 10 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = "worse," and 1 = "very much improved."
Measured: 10 months
BPLs and PIS 3 month follow up
Improvement in BPLs from Baseline to 1 Month follow-up (= 10 months maximum) via the Pigment Improvement Score (PIS) where a score of 0 = "no improvement" and a score of 4 = "Excellent response: Most or all lesions much lighter or gone"
Measured: 10 months
Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 1 month follow up
Improvement in the appearance of wrinkles from Baseline to 1 Month follow-up (= 10 months maximum) via the Investigator Fitzpatrick Wrinkle and Elastosis Scale where a score of 1 = "fine wrinkles or mild elastosis" and 9 = "deep wrinkles or severe elastosis".
Measured: 10 months
Wrinkles and Global Aesthetic Improvement Score (GAIS) 1 month follow up
Improvement in the appearance of wrinkles from Baseline to 1 Month follow-up (= 10 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = "worse," and 1 = "very much improved."
Measured: 10 months
Overall Subject Satisfaction 3 month follow up
Overall subject satisfaction with study treatments per treatment indication as measured by Subject Satisfaction Scale and Subject Global Aesthetic Improvement Score (SGAIS). (Baseline to 3 month follow up, approximately 12 months)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start28 Sep 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727099
- Sponsor's protocol ID
- PWY20001
- Status last verified
- Mar 2023
- First submitted
- 9 Oct 2020
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD plan.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™
- ClinicalTrials.gov ID
- NCT04727099
- Acronym / sponsor ID
- PWY20001
- Conditions
- Wrinkle, Pigmented Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Jan 2021 (actual)
- 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 study is intended to demonstrate the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles.
Detailed description
This is a prospective, non-randomized, open-label study evaluating the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles.
Up to 200 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to 6 treatments to the face and/or off-face locations with treatment intervals of 4 weeks +/- 2 weeks. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final treatment. Total study duration is approximately 12 months (up to 9 months for treatment and 3 months for follow up).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign Pigmented Lesions | Experimental | Device: PicoWay Laser SystemUp to six (6) treatments with PicoWay laser for treatment of benign pigmented lesions |
| Wrinkles | Experimental | Device: PicoWay Laser SystemUp to six (6) treatments with PicoWay laser for treatment of wrinkles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age or older
- Willingness to provide signed, informed consent to participate in the study
- Presence of mild or greater benign pigmented lesions, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) >/= 1.
- Willingness to adhere to study treatment and follow-up schedule
- Willingness to adhere to post-treatment care instructions
Key exclusion criteria (14 listed)
- Pregnant, planning pregnancy during the study, or breast feeding
- Tattooed skin in the intended treatment area unless tattoo removal treatment is to be performed.
- Active sun tan in the intended treatment area
- History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
- History of 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 |
|---|---|---|
| PicoWay Laser SystemThe PicoWay® laser system is an alexandrite laser pumped, solid-state Neodymium:Yttruium Aluminum Garnet (Nd:YAG) laser emitting energy at user selectable wavelengths of 1064 nm, 532 nm, 785 nm or 730 nm, designed for the treatment of tattoo, benign pigmented lesions, acne scars, and wrinkles. | Device | Benign Pigmented Lesions, Wrinkles |
Primary outcome
Benign Pigmented Lesions (BPLs) and Global Aesthetic Improvement Score (GAIS)
Time frame: 12 months
Improvement in Benign Pigmented Lesions (BPLs) from Baseline to 3 Month follow-up (= 12 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = "worse," and 1 = "very much improved."
Benign Pigmented Lesions (BPLs) and Pigment Improvement Score (PIS)
Time frame: 12 months
Improvement in Benign Pigmented Lesions (BPLs) from Baseline to 3 Month follow-up (= 12 months maximum) via the Pigment Improvement Score (PIS) where a score of 0 = "no improvement" and a score of 4 = "Excellent response: Most or all lesions much lighter or gone"
Wrinkles and Global Aesthetic Improvement Score (GAIS) 3 month follow up
Time frame: 12 months
Improvement in the appearance of wrinkles from Baseline 3 Month follow-up (= 12 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = "worse," and 1 = "very much improved."
Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 3 month follow up
Time frame: 12 months
Improvement in the appearance of wrinkles from Baseline 3 Month follow-up (= 12 months maximum) via the Investigator Fitzpatrick Wrinkle and Elastosis Scale where a score of 1 = "fine wrinkles or mild elastosis" and 9 = "deep wrinkles or severe elastosis".
5 secondary outcomes
BPLs and Global Aesthetic Improvement Score (GAIS) 1 month follow up
Time frame: 10 months
BPLs and PIS 3 month follow up
Time frame: 10 months
Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 1 month follow up
Time frame: 10 months
Wrinkles and Global Aesthetic Improvement Score (GAIS) 1 month follow up
Time frame: 10 months
Overall Subject Satisfaction 3 month follow up
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No. No IPD plan.
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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.
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 Laser System in people with Wrinkle and Pigmented Lesions, 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 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: status not confirmed, as of the sponsor's last update on 9 Mar 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?
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?
Benign Pigmented Lesions (BPLs) and Global Aesthetic Improvement Score (GAIS) (time frame: 12 months). The study lists 4 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 9 Mar 2023.