Pigmented Skin LesionNCT04202419
Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions
A study testing FRAX 1940 nm laser in people with Pigmented Skin Lesion, run by Candela Corporation at 1 site in United States.
Trial summary
This study is being conducted to evaluate the safety and efficacy of a fractional diode laser for treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles). Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pigmented Skin Lesion
- What is being tested?
- FRAX 1940 nm laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 26 Apr 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Age 21 to 70
- Fitzpatrick Skin Type I to VI
- Willingness to have test spots and up to three (3) treatments for pigmented lesions on or off the face which are rated at baseline as moderate or higher per Investigator or study staff
- Provide signed informed consent to participate in the study
- Adhere to study treatment and follow-up schedules
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- Willing to have hair removed from the intended treatment area prior to treatment and/or photography
- Avoid sun exposure to all treated areas and use of sunscreen with sun protection factor (SPF) 30 or greater throughout the duration of the study
- Adhere to post-treatment care instructions
- Allow photography of treated areas and to release their use for scientific and/or promotional purposes
Who cannot join
- Pregnant, planning to become pregnant, or breast feeding during the study
- Allergy to lidocaine or similar medications
- Excessively tanned skin in the intended treatment area
- Open wound or infection in the intended treatment area
- Tattoo(s) or permanent make-up in the intended treatment area
- Skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy
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- Presence or history of melasma
- Presence or history of skin cancer within the treatment area
- History of keloid or hypertrophic scar formation
- History of herpes simplex virus (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
- Diagnosed coagulation disorder
- Immunosuppression disorder
- Presence of any medical condition that in the opinion of the Investigator could impair healing or outcome as a result of treatment
- Use of systemic retinoid therapy (e.g. Accutane) during the past six (6) months
- Use of topical retinoid therapy in the intended treatment area during the past two (2) weeks
- Use of oral corticosteroid therapy during the past four (4) weeks
- Prior treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past three (3) months
- Prior injectable dermal fillers (e.g. collagen, hyaluronic acid) in the intended treatment area within the past 12 months
- Prior injectable toxins (e.g. Botox) in the intended treatment area within the past three (3) months
- Subjects who in the opinion of the Investigator are unwilling or unable to adhere to the study requirements, or who are otherwise not a good candidate for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Dermatology and Laser Institute
Miami, Florida, 33173
About this study
Official title: Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Treatment of Pigmented Lesions
This study is being conducted to evaluate the safety and efficacy of a fractional diode laser for treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles).
Read the detailed description
Prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for treatment of pigmented lesions.
Up to 60 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to three (3) treatments in the following treatment areas: face, hands, arms, back, chest, or legs. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final study treatment.
- Conditions
- Pigmented Skin Lesion
- Being tested
- FRAX 1940 nm laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRAX 1940 nm laserDevice
A fractional 1940 nm solid-state diode laser will deliver linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin, in order to treat pigmented skin lesions.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Single Arm: All subjects will undergo treatment of pigmented lesions with a 1940 nm diode laser Receives: Device: FRAX 1940 nm laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigmented Lesion Improvement by Blinded Evaluation
The primary efficacy endpoint was defined as improvement in the clearance of pigmented lesions, as assessed by three (3) blinded evaluators comparing photographs taken at Baseline/Pre-treatment and at the 1-month follow-up (post final treatment)
Measured: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Secondary outcomes (4)
Pigmentation Improvement at the 3-month Follow-up, by Blinded Evaluation
The secondary endpoint was pigmentation improvement at the 3-month follow-up, as assessed by three (3) blinded evaluators comparing photographs taken at Baseline/Pre-treatment and at the 3-month follow-up (post final treatment). The treated area was considered a "success" if at least two of the three reviewers correctly identified the post-treatment photograph (i.e. left or right side).
Measured: 3-months post final treatment, where treatment series could last up to 10 weeks after baseline
Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS)
For each reviewer assessment: If the post-treatment photograph was identified correctly, the reviewer's assessment on the textural scale was coded as follows: -1=worse, 0=no change; 1=improved; 2=much improved; and 3=very much improved. If not identified correctly, the scale was reversed (-1=improved, 0=no change, 1=worsened, 2=much worsened and 3=very much worsened). Results were based on the majority rule of the assessments by the three blinded reviewers; in other words, the mode of the three blinded reviewers' scores was used as the treated area clearance results, while the median was used if three different scores were reported.
Measured: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS)
Subject assessments of treatment outcome were completed at the 1-month follow-up using the Global Assessment Improvement Scale (GAIS). The scale was coded as follows: -1=worse, 0=no change; 1=improved; 2=much improved; and 3=very much improved
Measured: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Subject Satisfaction With Treatment Results
Subject satisfaction with treatment results completed at the 1-month follow-up using a 5 point scale coded as follows: -1=not satisfied, 0=little satisfied; 1=somewhat satisfied; 2=satisfied; and 3=very satisfied
Measured: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start9 Jan 2020
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
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 Pigmented Skin LesionStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Miami Dermatology and Laser Institute
- Responsible party
- Sponsor
- Investigators
- Jill S Waibel, M.D, Principal investigator, Miami Dermatology and Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202419
- Sponsor's protocol ID
- FRX19005
- Status last verified
- Jul 2023
- First submitted
- 16 Dec 2019
- Last updated
- 7 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Treatment of Pigmented Lesions
- ClinicalTrials.gov ID
- NCT04202419
- Acronym / sponsor ID
- FRX19005
- Conditions
- Pigmented Skin Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Miami Dermatology and Laser Institute
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Posted 7 Aug 2023
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 being conducted to evaluate the safety and efficacy of a fractional diode laser for treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles).
Detailed description
Prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for treatment of pigmented lesions.
Up to 60 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to three (3) treatments in the following treatment areas: face, hands, arms, back, chest, or legs. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Device: FRAX 1940 nm laserSingle Arm: All subjects will undergo treatment of pigmented lesions with a 1940 nm diode laser |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or Female
- Age 21 to 70
- Fitzpatrick Skin Type I to VI
- Willingness to have test spots and up to three (3) treatments for pigmented lesions on or off the face which are rated at baseline as moderate or higher per Investigator or study staff
- Provide signed informed consent to participate in the study
Key exclusion criteria (20 listed)
- Pregnant, planning to become pregnant, or breast feeding during the study
- Allergy to lidocaine or similar medications
- Excessively tanned skin in the intended treatment area
- Open wound or infection in the intended treatment area
- Tattoo(s) or permanent make-up 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 |
|---|---|---|
| FRAX 1940 nm laserA fractional 1940 nm solid-state diode laser will deliver linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin, in order to treat pigmented skin lesions. | Device | Single Group |
Primary outcome
Pigmented Lesion Improvement by Blinded Evaluation
Time frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
The primary efficacy endpoint was defined as improvement in the clearance of pigmented lesions, as assessed by three (3) blinded evaluators comparing photographs taken at Baseline/Pre-treatment and at the 1-month follow-up (post final treatment)
4 secondary outcomes
Pigmentation Improvement at the 3-month Follow-up, by Blinded Evaluation
Time frame: 3-months post final treatment, where treatment series could last up to 10 weeks after baseline
Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS)
Time frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS)
Time frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Subject Satisfaction With Treatment Results
Time frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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.
Jill S Waibel, M.D principal investigator
Miami Dermatology and Laser Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRAX 1940 nm laser in people with Pigmented Skin Lesion, 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 10 inclusion and 20 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 7 Aug 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 7 Aug 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?
Pigmented Lesion Improvement by Blinded Evaluation (time frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline). 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 7 Aug 2023.