enLighten Laser With MLA Handpiece for Treatment of Moderate and Severe Acne Scars

July 14, 2023 updated by: Cutera Inc.

Open-label, Prospective, Multicenter Study to Evaluate the Cutera enLighten™ Laser and a Micro-Lens Array Handpiece Attachment for the Treatment of Moderate and 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 Nd:YAG picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of acne scars.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, prospective, multicenter, pivotal study in up to 45 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of acne scars. Subjects will receive up to 6 laser treatments, spaced 6 weeks (± 2 weeks) apart with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will be contacted by phone 7 days (± 2 days) after their first treatment for follow-up. Subjects will return to the site after all study treatments have been delivered for two follow-up visits: 6 and 12 weeks (± 2 weeks) following their final study treatment.

  1. The Primary Efficacy Endpoint as the correct identification of the 12 weeks post final treatment photographs from the baseline by at least two of the three blinded reviewers in 75% of the patients and an improvement of one point in the ASAS.

  2. The Secondary Efficacy Endpoints as the:

    • Efficacy of the Cutera enlighten laser with the Micro-Lens Array handpiece attachment treatment as assessed by the investigator starting from the 2nd treatment onward, and
    • Subject satisfaction levels as assessed from the subject questionnaire completed at the final follow-up visit 12 weeks post final treatment.
  3. The Safety Endpoint as the safety of the Cutera enlighten laser with Micro-Lens Array handpiece attachment as assessed by the frequency and severity of device related adverse events,
  4. The Exploratory Analysis as the Efficacy of the Cutera enlighten laser with a Micro-Lens Array handpiece attachment for the improvement of skin quality as assessed by the investigator and/or blinded evaluators 12-weeks-post final study treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Brisbane, California, United States, 94005
        • Cutera Research Center
    • New York
      • New York, New York, United States, 10075
        • Sadick Dermatology/Sadick Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subject must be able to read, understand and sign the Informed Consent Form.
  2. Female or Male, 18 to 65 years of age (inclusive).
  3. Fitzpatrick Skin Type I - VI (Appendix 6).
  4. Subject desires treatment for acne scars and wishes to undergo laser treatments for improvement.
  5. Subject has bilateral moderate to severe signs of facial acne scarring.
  6. 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.
  7. 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.
  8. 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.
  9. 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.

  10. 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.,

    -

    Exclusion Criteria:

1. 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.

2. 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.

3. 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.

4. 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).

5. Pregnant and/or breastfeeding, or planning to become pregnant. 6. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.

7. Hypersensitivity to light exposure. 8. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.

9. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.

10. Has a history of squamous cell carcinoma or melanoma in the treatment area. 11. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.

12. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment.

13. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.

14. 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.

15. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation, or any that are considered not acceptable by the study investigator.

16. 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).

17. Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to refrain from tanning during the study.

19. Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment.

20. 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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: other
no arm
Device: other
no arm

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.
Time Frame: 12 weeks post-final treatment
visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)
12 weeks post-final treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1. Efficacy of Cutera enLighten device with MLA handpiece attachment as assessed by Investigator (GAIS).
Time Frame: 12 weeks post-screening through study completion, an average of 1 year.
GAIS =+3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement and 0=No Change.
12 weeks post-screening through study completion, an average of 1 year.
2. Satisfaction level and assessment of Acne Scar improvement as assessed by Subject.
Time Frame: 12 weeks post-final treatment
Satisfaction level and assessment of Acne Scar improvement
12 weeks post-final treatment
3. Efficacy of Cutera enLighten device with MLA handpiece attachment as assessed by Investigator (ASAS).
Time Frame: 12 weeks post-screening through study completion, an average of 1 year.
ASAS= Acne Scar Assessment Scale [1(clear), 2(Very Mild), 3(Mild), 4(Moderate) to 5(Severe)]
12 weeks post-screening through study completion, an average of 1 year.
4. Efficacy of Cutera enLighten device with MLA handpiece attachment as assessed by Investigator for Radiance, Smoothness, Pigmentation, Erythema and Pore size (Skin Quality Rating.)
Time Frame: 12 weeks post-screening through study completion, an average of 1 year.
Skin Quality Rating = scale: 1(No radiance) - 10(maximum radiance), 1(Very rough) - 10(Very smooth), 1=(Very irregular pigmentation) - 10(Very uniform pigmentation), 1=(Intense redness) - 10(No redness), 1=(Very large pores) - 10=Minimal pores)
12 weeks post-screening through study completion, an average of 1 year.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency and severity of device related Adverse Events of Cutera enLighten device with MLA handpiece attachment
Time Frame: through study completion, an average of 1 year.
Incidence of Treatment-emergent Adverse Events
through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cutera Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Neil Sadick, M.D., Sadick Dermatology/Sadick Research Center
  • Principal Investigator: Stephen Ronan, M.D., Cutera Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C-17-ML02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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