ClinicalTrials.gg
Active, not recruitingNCT06469398Updated Mar 17, 2025

A Post Market Device Study for the Treatment of Acne

An interventional study of Cutera Laser System in Acne Vulgaris, sponsored by Cutera Inc.. Active, not recruiting at 3 sites in United States. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-17.

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

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as active, not recruiting.
  • Registered 1 year 10 months after the study started (first participant enrolled Jul 2022, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
16 Years to 60 Years
Sex
All
01

Study summary

To evaluate the safety and efficacy of the Cutera laser system for the treatment of acne vulgaris.

02

Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 672 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris 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
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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. Female or Male, Fitzpatrick Skin Types I-VI, 16 to 60 years of age (inclusive).
  2. Has clinically diagnosed acne vulgaris of severity grade 3 - 4 (moderate to severe) on the face based on photographic review by expert dermatologist grader(s) using the Investigator's Global Assessment Scale.
  3. Has ≥ 10 inflammatory acne lesions on the face as determined by the Investigator (or qualified designee).
  4. Subject (and parent or legal guardian if subject is a minor under age 18) must be able to read, speak, and understand English and sign the Form.
  5. Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
  6. Willing to have very limited sun exposure (including avoiding tanning booths, sun lamps, sunbathing) and use an investigator approved sunblock or sunscreen of SPF 30 or higher on the face every day for the duration of the study, including the follow-up period.
  7. Must maintain the same acne treatment regimen, including topical and systemic medications for at least 2 weeks prior to enrollment, and for the duration of the study, including the follow-up period unless approved by the Investigator.
  8. Willing to have photographs taken of the face and agree to the use of photographs for presentation, educational or marketing purposes.
  9. Agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study unless approved by Investigator.
  10. Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  1. Has clinically diagnosed acne vulgaris of severity grade 0, 1, 2 (clear, almost clear, mild) on the face based on photographic review by expert dermatologist grader(s) using the Investigator's Global Assessment Scale.
  2. Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation.
  3. Still healing from another treatment in the target area according to investigator's discretion.
  4. Currently pregnant or planning on becoming pregnant anytime during the duration of the study.
  5. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that may preclude treatments, photos, or accurate acne lesion assessments in the target area.
  6. Currently undergoing treatment for skin cancer in the target area or undergoing systemic chemotherapy for the treatment of cancer.
  7. As per the Investigator's discretion, any physical, mental or medical condition which might make it unsafe for the subject to participate in this study or might interfere with patient's participation in the full study protocol.
  8. Known to, history of allergic reaction to, or to Pro-Nox or mild oral anti-anxiety or pain medication, if administered.
Terms in these criteria, in plain language(3)

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.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

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

Study arms

  • Experimental
    Laser Treatment

    Device: Cutera Laser System

Interventions

  • DeviceCutera Laser System

    Subjects will receive up to 6 laser treatments

06

What researchers measure

Primary outcomes

  1. Percent of Subjects Who are Responders

    The primary outcome measure to evaluate the efficacy of the Cutera device is the percent of subjects who are responders at 12 weeks post final treatment, where a responder is defined as ≥ 1-point reduction on the Investigator's Global Assessment scale at follow up compared to baseline.

    Time frame: 12 weeks post final treatment

07

Study locations

3 sites
  • Dermatology of Boca
    Boca Raton, Florida 33431, United States
  • Schweiger Dermatology PC, Reseach Division
    Hackensack, New Jersey 07601, United States
  • Bellaire Dermatology Associates
    Bellaire, Texas 77401, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06469398
Lead sponsor
Cutera Inc.
Responsible party
Sponsor
First posted
Jun 21, 2024
Start date
Jul 21, 2022
Primary completion
Mar 31, 2025 (estimated)
Completion
Aug 18, 2025 (estimated)
Last update
Mar 17, 2025

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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