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
To evaluate the safety and efficacy of the Cutera laser system for the treatment of 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 →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.
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.
Exclusion Criteria
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Cutera Laser System
Subjects will receive laser treatments
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
| Milestone | Laser Treatment |
|---|---|
| Started | 104 |
| Completed | 76 |
| Not completed | 28 |
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
| Participants | Laser Treatment |
|---|---|
| Percentage of Participants Achieving Treatment Success | 81 |
Collected over 1 year post final treatment, up to approximately 18 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Laser Treatment | 0/104 (0%) | 0/104 (0%) | 104/104 (100%) |
| Event | Laser Treatment |
|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 104/104 |
| EdemaSkin and subcutaneous tissue disorders | 102/104 |
| Acne PurgingSkin and subcutaneous tissue disorders | 47/104 |
| DrynessSkin and subcutaneous tissue disorders | 19/104 |
| Age, Continuous(years) | Laser Treatment |
|---|---|
| Mean | 22.2 ± 5.5 |
| Sex: Female, Male(Participants) | Laser Treatment |
|---|---|
| Female | 59 |
| Male | 45 |
| Ethnicity (NIH/OMB)(Participants) | Laser Treatment |
|---|---|
| Hispanic or Latino | 31 |
| Not Hispanic or Latino | 73 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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.
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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