ClinicalTrials.gg
CompletedNCT03430921Updated Sep 26, 2023Results posted

Evaluation of the Cutera Enlighten™ Laser With Micro-Lens Array (MLA) Handpiece Attachment

An interventional study of Enlighten™ Laser and a MLA Attachment in Scarring and Acne, sponsored by Cutera Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Cutera Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Aug 2017, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Scarring
  • Acne
03

In context

Cicatrix

611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.

This study's enrollment of 4 is below the median of 40 across 512 interventional studies indexed under Cicatrix.

Browse Cicatrix studies →

Lead sponsor

Cutera Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 19 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject must be able to read, understand and sign the Form.
  2. Female or Male, 18 to 65 years of age (inclusive).
  3. Fitzpatrick Skin Type I - VI.
  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 , surgically sterilized, or using a medically acceptable form of at least 3 months prior to enrollment and during the entire course of the study.,

Exclusion criteria

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, /immune deficiency disorders (including infection or AIDS) or using immunosuppressive medication.
  7. 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.
  18. Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment.
  19. 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Other
    Enlighten™ Laser and a MLA Attachment

    Enlighten™ Laser and a Micro-Lens Array Handpiece Attachment

    Device: Enlighten™ Laser and a MLA Attachment

Interventions

  • DeviceEnlighten™ Laser and a MLA Attachment

    Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, and at 12 weeks post final treatment (up to 30 weeks)

07

Results

Posted Sep 26, 2023

Participant flow

Participant flow — Overall Study
MilestoneEnlighten™ Laser and a MLA Attachment
Started4
Completed2
Not completed2

Outcome measures

PrimaryAcne 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

Time frame:
Baseline, and at 12 weeks post final treatment (up to 30 weeks)
Reported as:
Mean · score on a scale
Acne Scarring Improvement
score on a scaleEnlighten™ Laser and a MLA Attachment
Baseline Acne Scar Assessment Scale Score4 ± 0
12 weeks post final treatment Acne Scar Assessment Scale Score4 ± 0

Adverse events

Collected over 12 weeks post-final treatment, up to 8 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enlighten™ Laser and a MLA Attachment0/4 (0%)0/4 (0%)4/4 (100%)
Most frequent other events
Most frequent other events
EventEnlighten™ Laser and a MLA Attachment
ErythemaSkin and subcutaneous tissue disorders4/4
EdemaSkin and subcutaneous tissue disorders2/4
DiscomfortSkin and subcutaneous tissue disorders2/4

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Enlighten™ Laser and a MLA Attachment
<=18 years0
Between 18 and 65 years4
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Enlighten™ Laser and a MLA Attachment
Female1
Male3
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Enlighten™ Laser and a MLA Attachment
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American0
White2
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Cutera Research Center
    Brisbane, California 94005, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in May 2018, 9 months.

Results were first posted in Sep 2023, 5 years 3 months after primary completion.

Of 33 industry-sponsored interventional studies with no phase under Cicatrix, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 20. This study's 9 months is close to that.

Counting every sponsor, half of 206 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2018
First posted
Feb 13, 2018
StartActual
Aug 15, 2017
Primary completionActual
May 30, 2018
CompletionActual
May 30, 2018
Results first posted
Sep 26, 2023
Last update
Sep 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03430921
Lead sponsor
Cutera Inc.
Responsible party
Sponsor
First posted
Feb 13, 2018
Start date
Aug 15, 2017
Primary completion
May 30, 2018
Completion
May 30, 2018
Results posted
Sep 26, 2023
Last update
Sep 26, 2023

Study contacts

Stephen Ronan, M.D.
principal investigator · Cutera Research Center

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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