ScarringNCT03430921
Evaluation of the Cutera Enlighten™ Laser With Micro-Lens Array (MLA) Handpiece Attachment
A study testing Enlighten™ Laser and a MLA Attachment in people with Scarring and Acne, run by Cutera Inc. at 1 site in United States.
Trial summary
The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of moderate to severe acne scars. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Enlighten™ Laser and a MLA Attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 30 May 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be able to read, understand and sign the Informed Consent Form.
- Female or Male, 18 to 65 years of age (inclusive).
- Fitzpatrick Skin Type I - VI.
- Subject desires treatment for acne scars and wishes to undergo laser treatments for improvement.
- Subject has bilateral moderate to severe signs of facial acne scarring.
- Must be willing to have Cutera enlighten laser with the Micro-Lens Array handpiece attachment treatments and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions.
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- Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.
- Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation (educational and/or marketing), publications, and any additional marketing purposes.
- Agree to not undergo any other procedure(s) or treatment(s) for acne scars during the study and has no intention of having such procedures performed during the course of the study.
- 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 and during the entire course of the study.,
Who cannot join
- Participation in a clinical trial of another drug, or device administered to the treatment area, within 6 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser procedures, facial fillers, i.e. (Bellafill) and those used for general aesthetic correction, facial peel, lightening creams, or facial surgery.
- Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity.
- Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
- Pregnant and/or breastfeeding, or planning to become pregnant.
- Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.
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- Hypersensitivity to light exposure.
- Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.
- History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.
- Has a history of squamous cell carcinoma or melanoma in the treatment area.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
- A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment.
- History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation, or any that are considered not acceptable by the study investigator.
- Has used oral isotretinoin (Accutane or therapeutic vitamin A supplements of ≥ 10,000 units per day) 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 and peeling).
- Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to refrain from tanning during the study.
- Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Prospective, Multicenter Study to Evaluate the Cutera Enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the Treatment of Moderate to Severe Acne Scars
The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of moderate to severe acne scars.
Read the detailed description
This is an open-label, prospective, multicenter, pivotal study in approximately 15 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of moderate to severe acne scars. Subjects will receive laser treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will return to the site after all study treatments have been delivered for a follow-up visit at 12 weeks following their final study treatment.
- Being tested
- Enlighten™ Laser and a MLA Attachment
- Medical subject headings
- Cicatrix, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlighten™ Laser and a MLA AttachmentDevice
Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment.
| Study group | Role | What they receive |
|---|---|---|
| Enlighten™ Laser and a MLA Attachment | Other | Enlighten™ Laser and a Micro-Lens Array Handpiece Attachment Receives: Device: Enlighten™ Laser and a MLA Attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne Scarring Improvement
An improvement in Acne Scarring of at least one point on the Acne Scar Assessment Scale (ASAS):(1=clear scarring, 2=Very Mild scarring, 3=Mild scarring, 4=Moderate scarring or 5=Severe scarring) at the 12 weeks post final treatment
Measured: Baseline, and at 12 weeks post final treatment (up to 30 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start15 Aug 2017
- Primary completion30 May 2018
- Study completion30 May 2018
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 ScarringStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Ronan, M.D., Principal investigator, Cutera Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430921
- Sponsor's protocol ID
- C-17-ML03
- Status last verified
- Sep 2023
- First submitted
- 1 Feb 2018
- Last updated
- 26 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Prospective, Multicenter Study to Evaluate the Cutera Enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the Treatment of Moderate to Severe Acne Scars
- ClinicalTrials.gov ID
- NCT03430921
- Acronym / sponsor ID
- C-17-ML03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Posted 26 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of moderate to severe acne scars.
Detailed description
This is an open-label, prospective, multicenter, pivotal study in approximately 15 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of moderate to severe acne scars. Subjects will receive laser treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will return to the site after all study treatments have been delivered for a follow-up visit at 12 weeks following their 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 |
|---|---|---|
| Enlighten™ Laser and a MLA Attachment | Other | Device: Enlighten™ Laser and a MLA AttachmentEnlighten™ Laser and a Micro-Lens Array Handpiece Attachment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must be able to read, understand and sign the Informed Consent Form.
- Female or Male, 18 to 65 years of age (inclusive).
- Fitzpatrick Skin Type I - VI.
- Subject desires treatment for acne scars and wishes to undergo laser treatments for improvement.
- Subject has bilateral moderate to severe signs of facial acne scarring.
Key exclusion criteria (19 listed)
- Participation in a clinical trial of another drug, or device administered to the treatment area, within 6 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser procedures, facial fillers, i.e. (Bellafill) and those used for general aesthetic correction, facial peel, lightening creams, or facial surgery.
- Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity.
- Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
- Pregnant and/or breastfeeding, or planning to become pregnant.
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 |
|---|---|---|
| Enlighten™ Laser and a MLA AttachmentSubjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. | Device | Enlighten™ Laser and a MLA Attachment |
Primary outcome
Acne Scarring Improvement
Time frame: Baseline, and at 12 weeks post final treatment (up to 30 weeks)
An improvement in Acne Scarring of at least one point on the Acne Scar Assessment Scale (ASAS):(1=clear scarring, 2=Very Mild scarring, 3=Mild scarring, 4=Moderate scarring or 5=Severe scarring) at the 12 weeks post final treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stephen Ronan, M.D. principal investigator
Cutera Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enlighten™ Laser and a MLA Attachment in people with Scarring and Acne, run by Cutera Inc. 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 19 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 26 Sep 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 26 Sep 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?
Acne Scarring Improvement (time frame: Baseline, and at 12 weeks post final treatment (up to 30 weeks)). 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 26 Sep 2023.