A Device Study for the Treatment of Acne

A study testing Cutera Laser System in people with Acne Vulgaris, run by Cutera Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the safety and efficacy of the Cutera laser system for the treatment of acne vulgaris. Read more about this study

Who is it for?: Ages 16 to 60 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Cutera Laser System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 7 sitesUnited States
Study dates: 15 Dec 2020to 7 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 60 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Female or Male, 16 to 60 years of age (inclusive)
Fitzpatrick Skin Type I-VI
Has clinically diagnosed acne vulgaris of severity grade 2 - 4 on the face using the Investigator's Global Assessment Scale.
Has inflammatory acne lesions on the face as determined by the Investigator (or qualified designee).
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 Informed Consent Form.
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 washout applies to use on the face only.

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Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
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.
Willing to have photographs taken of the face and agree to the use of photographs for presentation, educational or marketing purposes.
Agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study.

Who cannot join

Has clinically diagnosed acne vulgaris of severity grade 0 or 1 on the face using the Investigator's Global Assessment Scale.
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.
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 steroids, photodynamic therapy, or acne surgery.
Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study.
Prior injection of collagen, hyaluronic acid filler or other dermal filler in the target area within 6 weeks of study participation.
Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.

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History of malignant tumors in the target area.
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).
Pregnant and/or breastfeeding or planning to become pregnant during the study.
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.
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).
Suffering from diagnosed coagulation disorders or taking prescription anticoagulation medications.
History of diagnosed immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
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 target area, unless treatment is conducted following a prophylactic regimen.
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.
History of diagnosed pigmentary disorders (including vitiligo) in the target area.
Excessively tanned on the face or unable/unlikely to refrain from tanning on the face during the study.
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

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

Other trials in United States

About this study

Official title: A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris

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

Conditions: Acne Vulgaris
Being tested: Cutera Laser System
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cutera Laser SystemDevice
Subjects will receive laser treatments

Study groups in NCT04695691
Study group	Role	What they receive
Laser Treatment	Experimental	Not described Receives: Device: Cutera Laser System

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 weeks post final treatment, up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 20207 Dec 2022

First posted5 Jan 2021
Study start15 Dec 2020
Primary completion9 Oct 2021
Study completion7 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04695691
Sponsor's protocol ID: C-20-PAC01
Status last verified: Oct 2023
First submitted: 3 Jan 2021
Last updated: 2 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris
ClinicalTrials.gov ID: NCT04695691
Acronym / sponsor ID: C-20-PAC01
Conditions: Acne Vulgaris
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Cutera Inc.Industry (pharma, biotech, devices)
Study start: 15 Dec 2020 (actual)
Primary completion: 9 Oct 2021 (actual)
Study completion: 7 Dec 2022 (actual)
First posted: 5 Jan 2021 (actual)
Results: Posted 2 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Laser Treatment	Experimental	Device: Cutera Laser System

Who may qualify

Ages: 16 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

Female or Male, 16 to 60 years of age (inclusive)
Fitzpatrick Skin Type I-VI
Has clinically diagnosed acne vulgaris of severity grade 2 - 4 on the face using the Investigator's Global Assessment Scale.
Has inflammatory acne lesions on the face as determined by the Investigator (or qualified designee).
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 Informed Consent Form.

Key exclusion criteria (20 listed)

Has clinically diagnosed acne vulgaris of severity grade 0 or 1 on the face using the Investigator's Global Assessment Scale.
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.
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 steroids, photodynamic therapy, or acne surgery.
Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study.
Prior injection of collagen, hyaluronic acid filler or other dermal filler in the target area within 6 weeks of study participation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cutera Laser SystemSubjects will receive laser treatments	Device	Laser Treatment

Primary outcome

Percentage of Participants Achieving Treatment Success
Time frame: 12 weeks post final treatment, up to 24 weeks
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

Results and safety

Results posted to the registry on 2 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Laser Treatment	104	76

Primary outcome: Percentage of Participants Achieving Treatment Success

Time frame: 12 weeks post final treatment, up to 24 weeks. Count of participants. Unit: Participants

Measure	Laser Treatment n = 104
Value	81

Adverse events

Time frame: 1 year post final treatment, up to approximately 18 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Laser Treatment	0 of 104 (0%)	104 of 104 (100%)	0 of 104

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cutera Laser System in people with Acne Vulgaris, run by Cutera Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Treatment Success (time frame: 12 weeks post final treatment, up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04695691.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.