Acne VulgarisNCT06469398
A Post Market Device Study for the Treatment of Acne
A study testing Cutera Laser System in people with Acne Vulgaris, run by Cutera Inc. at 3 sites in United States.
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
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Jul 2022to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, Fitzpatrick Skin Types I-VI, 16 to 60 years of age (inclusive).
- 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.
- Has ≥ 10 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 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 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.
Show all 10Show fewer
- 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.
- 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 unless approved by Investigator.
- Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.
Who cannot join
- 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.
- 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.
- Still healing from another treatment in the target area according to investigator's discretion.
- Currently pregnant or planning on becoming pregnant anytime during the duration of the study.
- Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that may preclude treatments, photos, or accurate acne lesion assessments in the target area.
- Currently undergoing treatment for skin cancer in the target area or undergoing systemic chemotherapy for the treatment of cancer.
- 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.
- Known hypersensitivity to, history of allergic reaction to, or contraindication to Pro-Nox or mild oral anti-anxiety or pain medication, if administered.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Dermatology of Boca
Boca Raton, Florida, 33431
Schweiger Dermatology PC, Reseach Division
Hackensack, New Jersey, 07601
About this study
Official title: A Post Market Study of a Laser System 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 up to 6 laser treatments
| 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.
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.
Measured: 12 weeks post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start21 Jul 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion18 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469398
- Sponsor's protocol ID
- C-22-AC05
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Study of a Laser System for the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06469398
- Acronym / sponsor ID
- C-22-AC05
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 18 Aug 2025 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
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, Fitzpatrick Skin Types I-VI, 16 to 60 years of age (inclusive).
- 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.
- Has ≥ 10 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 and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
Key exclusion criteria (8 listed)
- 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.
- 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.
- Still healing from another treatment in the target area according to investigator's discretion.
- Currently pregnant or planning on becoming pregnant anytime during the duration of the study.
- Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that may preclude treatments, photos, or accurate acne lesion assessments in the target area.
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 up to 6 laser treatments | Device | Laser Treatment |
Primary outcome
Percent of Subjects Who are Responders
Time frame: 12 weeks post final treatment
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- 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
Hair Reduction, Tattoo Removal
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.
3 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 3 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 8 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: status not confirmed, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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?
Percent of Subjects Who are Responders (time frame: 12 weeks post final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2025.