Acne VulgarisNCT05430464
A Study of a Laser for the Treatment of Acne Vulgaris
A study testing 1726nm Laser System in people with Acne Vulgaris, run by Cutera Inc. at 2 sites in Canada.
Trial summary
The purpose of this study is to evaluate the onset, duration, efficacy and safety of the laser for the treatment of acne vulgaris. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- 1726nm Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 27 Jul 2022to Oct 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female or Male, 16 to 50 years of age (inclusive).
- Fitzpatrick Skin Type I-VI
- Has clinically diagnosed acne vulgaris of moderate to severe on each hemiface and inflammatory acne lesions as determined by the blinded trained investigator (or qualified designee) using the Investigator's Global Assessment Scale.
- Subject (and legally authorized representative/substitute decision maker if subject is incapable of providing informed consent) must be able to read, speak, and understand English and sign the Informed Consent Form.
- Willing to stop using topical acne medications on the face for 2 weeks prior to baseline and systemic acne medications for 1 month prior to baseline and for the duration of the study.
- Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
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- Willing to have very limited sun exposure (including avoiding tanning booths, sun lamps, sunbathing) and use an approved sunblock or sunscreen of SPF (Skin Protection Factor) 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 of clear, almost clear, or mild on at least one hemiface as determined by the blinded trained investigator (or qualified designee) 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 1 month of study participation including chemical peel, dermabrasion/microdermabrasion, 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 1 month of study participation and for the duration of the study.
- Prior injection of collagen, hyaluronic acid filler or other dermal/tissue filler in the target area within 2 weeks of study participation.
- Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
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- Started or changed hormonal contraception within 6 months of study participation or intends to start or change hormonal contraception through duration of the study. If subject has not changed hormonal contraception within 6 months of study participation and has intent of continuation through duration of this study, ok to enroll.
- History of malignant tumors in the target area.
- Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) or facial adornments (studs, piercings, tattoos) that may preclude treatments, photos or accurate lesion assessments in the target area.
- 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.
- Known hypersensitivity to, history of allergic reaction to, or contraindication to Pro-Nox (or similar) if administered.
- 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.
- Facial tan 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
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Canadian Dermatology Centre
Toronto, Ontario, M3B 0A7
Michelle Mooney, 416-244-8377
Renita Ahluwalia, MD
- Recruiting
Windsor Clinical Research
Windsor, Ontario, N8W 5L7
Shannon Moore, 519-971-7693, wcri@bellnet.ca
Jerry Tan, MD
About this study
Official title: A Randomized, Controlled, Split Face Study of a 1726 nm Laser for the Treatment of Acne Vulgaris
The purpose of this study is to evaluate the onset, duration, efficacy and safety of the laser for the treatment of acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- 1726nm Laser System, Sham 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.
1726nm Laser SystemDevice
Subjects will receive 1726nm laser treatments on one side of the face
Sham Laser SystemDevice
Subjects will receive sham laser treatments on the other side of the face.
| Study group | Role | What they receive |
|---|---|---|
| 1726nm Laser Treatment | Experimental | Not described Receives: Device: 1726nm Laser System |
| Sham Laser Treatment | Sham comparator | Not described Receives: Device: Sham Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects having at least a 1 point reduction on the Investigator Global Assessment Scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start27 Jul 2022
- Primary completionApr 2023 (estimated)
- Study completionOct 2024 (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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430464
- Sponsor's protocol ID
- C-22-AC04
- Status last verified
- Sep 2022
- First submitted
- 20 Jun 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- 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 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Split Face Study of a 1726 nm Laser for the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT05430464
- Acronym / sponsor ID
- C-22-AC04
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 24 Jun 2022 (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.
The purpose of this study is to evaluate the onset, duration, efficacy and safety of the laser for the treatment of acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1726nm Laser Treatment | Experimental | Device: 1726nm Laser System |
| Sham Laser Treatment | Sham comparator | Device: Sham Laser System |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Female or Male, 16 to 50 years of age (inclusive).
- Fitzpatrick Skin Type I-VI
- Has clinically diagnosed acne vulgaris of moderate to severe on each hemiface and inflammatory acne lesions as determined by the blinded trained investigator (or qualified designee) using the Investigator's Global Assessment Scale.
- Subject (and legally authorized representative/substitute decision maker if subject is incapable of providing informed consent) must be able to read, speak, and understand English and sign the Informed Consent Form.
- Willing to stop using topical acne medications on the face for 2 weeks prior to baseline and systemic acne medications for 1 month prior to baseline and for the duration of the study.
Key exclusion criteria (22 listed)
- Has clinically diagnosed acne vulgaris of severity grade of clear, almost clear, or mild on at least one hemiface as determined by the blinded trained investigator (or qualified designee) 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 1 month of study participation including chemical peel, dermabrasion/microdermabrasion, 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 1 month of study participation and for the duration of the study.
- Prior injection of collagen, hyaluronic acid filler or other dermal/tissue filler in the target area within 2 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 |
|---|---|---|
| 1726nm Laser SystemSubjects will receive 1726nm laser treatments on one side of the face | Device | 1726nm Laser Treatment |
| Sham Laser SystemSubjects will receive sham laser treatments on the other side of the face. | Device | Sham Laser Treatment |
Primary outcome
Percent of subjects having at least a 1 point reduction on the Investigator Global Assessment Scale
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1726nm Laser System in people with Acne Vulgaris, run by Cutera Inc. at 2 sites in Canada.
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 9 inclusion and 22 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 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. 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?
Contact Spencer Royea (415-657-5531, sroyea@cutera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of subjects having at least a 1 point reduction on the Investigator Global Assessment Scale (time frame: 12 weeks). 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 4 Oct 2022.