An interventional study of excel V Laser in Skin Pigment and Photoaging, sponsored by Cutera Inc.. Completed at 1 site in United States. Open to participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Cutera Inc. · Not applicable, Interventional, and Other
The purpose of this investigation is to evaluate the safety and efficacy of the Cutera excel V Laser Genesis procedure utilizing the 1064nm laser for skin rejuvenation.
This is a single-center prospective, open-label uncontrolled study in 15 male or female subjects, age 35 to 55 years who desire non-ablative laser treatment for facial photo-rejuvenation, specifically improvement of rhytides, lentigines, erythema, telangiectasia and skin texture. Subjects will receive laser treatments and complete a follow up visit 12 weeks post-final treatment.
57 studies on the registry are indexed under Pigmentation Disorders; 12 are open to participants now.
This study's enrollment of 17 is below the median of 35 across 44 interventional studies indexed under Pigmentation Disorders.
Browse Pigmentation Disorders 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:
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
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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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
excel V Laser Genesis procedure utilizing 1064 nm laser
Device: excel V Laser
excel V Laser Genesis procedure utilizing 1064 nm laser
Degree of Improvement Rating at 12 Weeks Post-final Treatment
The degree of improvement from Baseline observed in the post-treatment photographs at 12 weeks as assessed by independent blinded Reviewers using the Physician's Global Assessment of Improvement Scale (GAIS) Higher scores indicate better outcomes * 4=Very Significant Improvement * 3=Significant Improvement * 2=Moderate Improvement * 1=Mild Improvement 0=No Change(
Time frame: 12 weeks post-final treatment
| Milestone | Excel V Laser |
|---|---|
| Started | 16 |
| Completed | 10 |
| Not completed | 6 |
The degree of improvement from Baseline observed in the post-treatment photographs at 12 weeks as assessed by independent blinded Reviewers using the Physician's Global Assessment of Improvement Scale (GAIS) Higher scores indicate better outcomes * 4=Very Significant Improvement * 3=Significant Improvement * 2=Moderate Improvement * 1=Mild Improvement 0=No Change(
| score on a scale | Excel V Laser |
|---|---|
| Degree of Improvement Rating at 12 Weeks Post-final Treatment | 1.4 ± 0.8 |
Collected over 12 weeks post-final treatment, up to 9 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Excel V Laser | 0/16 (0%) | 0/16 (0%) | 16/16 (100%) |
| Event | Excel V Laser |
|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 16/16 |
| EdemaSkin and subcutaneous tissue disorders | 2/16 |
| Age, Continuous(years) | Excel V Laser |
|---|---|
| Mean | 46.9 ± 7.3 |
| Sex: Female, Male(Participants) | Excel V Laser |
|---|---|
| Female | 14 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Excel V Laser |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2016 to primary completion in Feb 2018, 22 months.
Results were first posted in Sep 2023, 5 years 6 months after primary completion.
Of 21 interventional studies with no phase under Pigmentation Disorders, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 10. This study's 22 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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