Skin TextureNCT04203745
Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions
A study testing Nonablative Fractional Diode Laser in people with Skin Texture and Pigmented Lesions, run by Candela Corporation at 1 site in United States.
Trial summary
This study is intended to evaluate the efficacy and safety of a new diode fractional laser for skin resurfacing and treatment of pigmented lesions. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Texture, Pigmented Lesions
- What is being tested?
- Nonablative Fractional Diode Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2019to 5 Aug 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 V
- Willingness to have test spots and up to three (3) skin resurfacing treatments on the face
- Presence of pigmented lesions to be treated off the face must be rated at baseline as moderate or higher per Investigator or study staff
- Provide signed informed consent to participate in the study
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- Adhere to study treatment and follow-up schedules
- 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(s)
- 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
- 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 skin resurfacing treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past six (6) months
- Prior injectable dermal fillers in the intended treatment areas within the past twelve (12) months
- Prior injectable toxins (Botox) in the treated areas 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
Candela Institute for Excellence
Marlborough, Massachusetts, 01752
About this study
Official title: Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Skin Resurfacing and Treatment of Pigmented Lesions
This study is intended to evaluate the efficacy and safety of a new diode fractional laser for skin resurfacing and treatment of pigmented lesions.
Read the detailed description
This study is a prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for skin resurfacing.
Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will receive up to 4 treatments to the face, and other off-face locations may be treated. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final treatment.
- Conditions
- Skin Texture, Pigmented Lesions
- Being tested
- Nonablative Fractional Diode Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonablative Fractional Diode LaserDevice
The FRAX 1940 is a fractional 1940 nm solid-state diode laser that delivers linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin.
| Study group | Role | What they receive |
|---|---|---|
| Nonablative Fractional Diode Laser | Experimental | Single Group - single arm study. Group was treated with Nonablative Fractional Diode Laser Receives: Device: Nonablative Fractional Diode 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 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start18 Sep 2019
- Primary completion30 Apr 2021
- Study completion5 Aug 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 Skin TextureStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konika P Schallen, M.D., Principal investigator, Candela Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203745
- Sponsor's protocol ID
- FRX19004
- Status last verified
- Jul 2023
- First submitted
- 10 Dec 2019
- Last updated
- 1 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 1 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 Skin Resurfacing and Treatment of Pigmented Lesions
- ClinicalTrials.gov ID
- NCT04203745
- Acronym / sponsor ID
- FRX19004
- Conditions
- Skin Texture, Pigmented Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Posted 1 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 intended to evaluate the efficacy and safety of a new diode fractional laser for skin resurfacing and treatment of pigmented lesions.
Detailed description
This study is a prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for skin resurfacing.
Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will receive up to 4 treatments to the face, and other off-face locations may be treated. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonablative Fractional Diode Laser | Experimental | Device: Nonablative Fractional Diode LaserSingle Group - single arm study. Group was treated with Nonablative Fractional Diode Laser |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or Female
- Age 21 to 70
- Fitzpatrick Skin Type I to V
- Willingness to have test spots and up to three (3) skin resurfacing treatments on the face
- Presence of pigmented lesions to be treated off the face must be rated at baseline as moderate or higher per Investigator or study staff
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 |
|---|---|---|
| Nonablative Fractional Diode LaserThe FRAX 1940 is a fractional 1940 nm solid-state diode laser that delivers linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin. | Device | Nonablative Fractional Diode Laser |
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 from 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
Konika P Schallen, M.D. principal investigator
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 Nonablative Fractional Diode Laser in people with Skin Texture 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 11 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 1 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 1 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 from 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 1 Aug 2023.