ClinicalTrials.gg
CompletedNCT04695691Updated Nov 2, 2023Results posted

A Device Study for the Treatment of Acne

An interventional study of Cutera Laser System in Acne Vulgaris, sponsored by Cutera Inc.. Completed at 7 sites in United States. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-02.

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

Phase
Not applicable
Study type
Interventional
Enrollment
104
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 104 is above 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, 16 to 60 years of age (inclusive)
  2. Fitzpatrick Skin Type I-VI
  3. Has clinically diagnosed acne vulgaris of severity grade 2 - 4 on the face using the Investigator's Global Assessment Scale.
  4. Has inflammatory acne lesions on the face as determined by the Investigator (or qualified designee).
  5. 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.
  6. Willing to stop using topical retinoids and other acne medications for 1 month (30 days) prior to baseline and for the duration of the study. If the acne medication is topical, the applies to use on the face only.
  7. Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
  8. Willing to have very limited sun exposure (including avoiding tanning booths, sun lamps, sunbathing) and use an approved sunscreen of SPF 30 or higher on the face every day for the duration of the study, including the follow-up period.
  9. Willing to have photographs taken of the face and agree to the use of photographs for presentation, educational or marketing purposes.
  10. Agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study.

Exclusion criteria

Exclusion Criteria

  1. Has clinically diagnosed acne vulgaris of severity grade 0 or 1 on the face 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. Prior treatment to the target area within 3 months of study participation including chemical peel, dermabrasion, microneedling, radiofrequency treatment, laser or light-based procedures, cryodestruction or chemodestruction, intralesional , photodynamic therapy, or acne surgery.
  4. Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study.
  5. Prior injection of collagen, hyaluronic acid filler or other dermal filler in the target area within 6 weeks of study participation.
  6. Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
  7. History of malignant tumors in the target area.
  8. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris in the target area (okay if shaved).
  9. Pregnant and/or breastfeeding or planning to become pregnant during the study.
  10. Presence of any skin condition in the target area (e.g. eczema, psoriasis, dermatitis, rash, papulo-pustular rosacea, infection) that would interfere with the diagnosis or assessment of acne vulgaris.
  11. Any medical condition that, in the opinion of the Investigator, would interfere with patient's participation in the full study protocol (e.g. severe Diabetes Mellitus or Cardiovascular Disease).
  12. Suffering from diagnosed coagulation disorders or taking prescription anticoagulation medications.
  13. History of diagnosed /immune deficiency disorders or currently using immunosuppressive medications.
  14. History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
  15. Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
  16. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the target area, unless treatment is conducted following a prophylactic regimen.
  17. History of radiation to the target area, currently undergoing treatment for skin cancer in the target area, or undergoing systemic chemotherapy for the treatment of cancer.
  18. History of diagnosed pigmentary disorders (including vitiligo) in the target area.
  19. Excessively tanned on the face or unable/unlikely to refrain from tanning on the face during the study.
  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.
Terms in these criteria, in plain language(4)

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.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

05

Study design

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

Study arms

  • Experimental
    Laser Treatment

    Device: Cutera Laser System

Interventions

  • DeviceCutera Laser System

    Subjects will receive laser treatments

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Treatment Success

    Primary effectiveness objective was to show more than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline

    Time frame: 12 weeks post final treatment, up to 24 weeks

07

Results

Posted Nov 2, 2023

Participant flow

Participant flow — Overall Study
MilestoneLaser Treatment
Started104
Completed76
Not completed28

Outcome measures

PrimaryPercentage of Participants Achieving Treatment Success

Primary effectiveness objective was to show more than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline

Time frame:
12 weeks post final treatment, up to 24 weeks
Reported as:
Count of participants · Participants
Percentage of Participants Achieving Treatment Success
ParticipantsLaser Treatment
Percentage of Participants Achieving Treatment Success81

Adverse events

Collected over 1 year post final treatment, up to approximately 18 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Laser Treatment0/104 (0%)0/104 (0%)104/104 (100%)
Most frequent other events
Most frequent other events
EventLaser Treatment
ErythemaSkin and subcutaneous tissue disorders104/104
EdemaSkin and subcutaneous tissue disorders102/104
Acne PurgingSkin and subcutaneous tissue disorders47/104
DrynessSkin and subcutaneous tissue disorders19/104

Baseline characteristics

Age, Continuous
Age, Continuous(years)Laser Treatment
Mean22.2 ± 5.5
Sex: Female, Male
Sex: Female, Male(Participants)Laser Treatment
Female59
Male45
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Laser Treatment
Hispanic or Latino31
Not Hispanic or Latino73
Unknown or Not Reported0
08

Study locations

7 sites
  • Cutera Research Center
    Brisbane, California 94005, United States
  • Blackhawk Plastic Surgery
    Danville, California 94506, United States
  • Center for Dermatology Clinical Research, Inc
    Fremont, California 94538, United States
  • Laser and Skin Surgery Center of Northern CA
    Sacramento, California 95816, United States
  • Kwan Dermatology
    San Francisco, California 94108, United States
  • Skin Research Institute
    Coral Gables, Florida 33146, United States
  • Skin Laser & Surgery Specialists, a Division of Schweiger Dermatology
    Hackensack, New Jersey 07601, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

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 Dec 2020 to primary completion in Oct 2021, 9 months.

Results were first posted in Nov 2023, 2 years after primary completion.

Of 62 industry-sponsored interventional studies with no phase under Acne Vulgaris, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's 9 months is close to that.

Counting every sponsor, half of 120 studies reached it within 9 months; a quarter within 4 and three quarters within 18.

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

Registered
Jan 3, 2021
First posted
Jan 5, 2021
StartActual
Dec 15, 2020
Primary completionActual
Oct 9, 2021
CompletionActual
Dec 7, 2022
Results first posted
Nov 2, 2023
Last update
Nov 2, 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 Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04695691
Lead sponsor
Cutera Inc.
Responsible party
Sponsor
First posted
Jan 5, 2021
Start date
Dec 15, 2020
Primary completion
Oct 9, 2021
Completion
Dec 7, 2022
Results posted
Nov 2, 2023
Last update
Nov 2, 2023

Oversight

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

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

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