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CompletedNCT02888626Updated Aug 15, 2023Results posted

Study of a Novel Microlens Array Device for Skin Rejuvenation

An interventional study of Microlens Array in Wrinkles and Scars, sponsored by Cutera Inc.. Completed at 1 site in United States. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-15.

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

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
20 Years to 75 Years
Sex
All
01

Study summary

A single-center prospective, open-label uncontrolled pilot study. Subjects will receive laser treatments and will be followed at 12 weeks post-final treatment.

02

Conditions studied

  • Wrinkles
  • Scars
03

In context

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
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female or Male, 20 to 75 years of age (inclusive). Fitzpatrick Skin Type I - VI.
  • Desires photo-rejuvenation of the skin or improvement in the appearance of acne scarring.
  • Subject has visible signs of acne scarring or moderate sun-damaged and/or aging skin in the treatment area with visible areas of fine rhytides, pigmentation, erythema or telangiectasia.
  • Subject must be able to read, understand and sign the Informed Consent Form.
  • Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
  • Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher 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 or marketing purposes.
  • Agree to not undergo any other procedure(s), including injectable agents, for skin rejuvenation during the study and has no intention of having such procedures performed during the course of the study.
  • Post-menopausal or 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, and no plans to become pregnant.

Exclusion criteria

Exclusion Criteria:

  • Participation in a clinical trial of another drug, or device administered to the target 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 or light-based procedures or surgery.
  • Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation.
  • History of malignant tumors in the target area.
  • Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
  • Pregnant and/or breastfeeding.
  • Having an infection, dermatitis or a rash in the treatment area.
  • Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
  • Suffering from coagulation disorders or taking prescription anticoagulation medications.
  • History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
  • History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
  • History of vitiligo, eczema, or psoriasis. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
  • History of seizure disorders due to light.
  • Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
  • 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 radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
  • History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
  • Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
  • Topical use of retinoid, such as isotretinoin, corticosteroid or hydroquinone, as applicable, on the treatment area within 1 month of participation.
  • Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  • Current smoker or history of smoking within 6 months of study participation. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
05

Study design

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

Study arms

  • Experimental
    Treatment with Microlens Array

    Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser

    Device: Microlens Array

Interventions

  • DeviceMicrolens Array

    Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser

06

What researchers measure

Primary outcomes

  1. Physician's Global Assessment of Improvement

    Degree of improvement at 12 weeks post-final treatment as assessed by the Investigator. Higher scores indicate better outcomes 3= Very significant Improvement 2= Significant Improvement 1= Moderate Improvement 0= Mild or No Improvement

    Time frame: 12 weeks post final treatment

07

Results

Posted Aug 15, 2023

Participant flow

Participant flow — Overall Study
MilestoneTreatment With Microlens Array
Started7
Completed7
Not completed0

Outcome measures

PrimaryPhysician's Global Assessment of Improvement

Degree of improvement at 12 weeks post-final treatment as assessed by the Investigator. Higher scores indicate better outcomes 3= Very significant Improvement 2= Significant Improvement 1= Moderate Improvement 0= Mild or No Improvement

Time frame:
12 weeks post final treatment
Reported as:
Mean · score on a scale
Physician's Global Assessment of Improvement
score on a scaleTreatment With Microlens Array
Physician's Global Assessment of Improvement2 ± 0.76

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Treatment With Microlens Array0/7 (0%)0/7 (0%)7/7 (100%)
Most frequent other events
Most frequent other events
EventTreatment With Microlens Array
ErythemaSkin and subcutaneous tissue disorders7/7
PetechiaeSkin and subcutaneous tissue disorders4/7
EdemaSkin and subcutaneous tissue disorders3/7

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment With Microlens Array
<=18 years0
Between 18 and 65 years6
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)Treatment With Microlens Array
Female5
Male2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment With Microlens Array
American Indian or Alaska Native0
Asian3
Native Hawaiian or Other Pacific Islander0
Black or African American0
White4
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

  • Protocol and statistical analysis plan · Jun 16, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02888626
Lead sponsor
Cutera Inc.
Responsible party
Sponsor
First posted
Sep 5, 2016
Start date
Aug 2016
Primary completion
Feb 6, 2017
Completion
Feb 6, 2017
Results posted
Aug 15, 2023
Last update
Aug 15, 2023

Study contacts

Stephen Ronan, MD
principal investigator · P.I.

Oversight

FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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