An interventional study of Excel V™ Laser With Green Genesis in Wrinkle, Rosacea and Scarring, sponsored by Cutera Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-23.
Sponsored by Cutera Inc. · Not applicable, Interventional, and Other
Among 145 studies in Rosacea with a site in United States — 8 open to participants now, 9 under way, none of them phase 3. Rosacea · United States.
Among the 145 studies in Rosacea with a site in United States, this one is the 110th largest by enrollment of the 137 interventional ones that give a count, is one of 17 that started in 2017, is one of 23 with no phase, and was the 97th registered.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
Browse Rosacea studies →8 of the 145 studies in Rosacea with a site in United States are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States, Bulgaria, Canada and 6 more countries
Ages 18+
Brigham and Women's Hospital · Sites in United States
Ages 18+
Narrows Institute for Biomedical Research · Sites in United States
Ages 18+ · Healthy volunteers
University of Miami · Sites in United States
Ages 18+
Wright State University · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 17 Rosacea studies recruiting now, 9 (53%) set no upper age limit and 7 (41%) stop at 75 or younger; 1 takes children under 18; 8 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
145 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 44 · Phase 3 34 · Phase 4 20
First in 2002; this study’s year is marked. 17 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Median enrollment 78 across the 137 interventional studies, 236 across the 8 observational. Of the 127 that completed or were terminated, 76 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
98 of 145 have an industry lead sponsor. The 10 most frequent:
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.
Cutera Inc. has 2 studies filed under Rosacea — fewer than ten, so there is no comparison to draw.
3 of the studies in Rosacea with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07443202Tarsus Pharmaceuticals, Inc.Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE) | 2026-12-31 |
| NCT06801717University of MiamiRosacea Radiofrequency Microneedling | 2027-07-01 |
| NCT04108897Johns Hopkins UniversityAnalysis of the Microbiome in Rosacea | 2027-09 |
Add all 3 to your calendar (.ics) → With an account.
Among the 145 studies in Rosacea with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array (MLA) Attachment
This is an open-label, prospective, single-center, split-face Feasibility study to Evaluate 1) the safety and efficacy of the Cutera excel V™ laser and the Micro-Lens Array attachment to the Genesis V hand piece, and 2) the safety and efficacy of the Cutera excel V™ laser Green Genesis V hand piece to the CoolView hand piece.
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.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment for skin quality in desired area
Device: Excel V™ Laser With Green Genesis
Subject(s) will receive treatments with a Cutera Excel V™ Laser
Global Aesthetic Improvement Scale
The improvement after treatment on the Global Aesthetic Improvement Scale (GAIS). Higher scores mean 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 With Green Genesis |
|---|---|
| Started | 20 |
| Completed | 19 |
| Not completed | 1 |
The improvement after treatment on the Global Aesthetic Improvement Scale (GAIS). Higher scores mean 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 With Green Genesis |
|---|---|
| Right side of the face | 0.95 ± 1.40 |
| Left side of the face | 1.05 ± 1.28 |
Collected over Up to 12 weeks post-final treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Excel V™ Laser With Green Genesis | 0/20 (0%) | 0/20 (0%) | 20/20 (100%) |
| Event | Excel V™ Laser With Green Genesis |
|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 20/20 |
| EdemaSkin and subcutaneous tissue disorders | 12/20 |
| Age, Categorical(Participants) | Excel V™ Laser With Green Genesis |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Excel V™ Laser With Green Genesis |
|---|---|
| Female | 16 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Excel V™ Laser With Green Genesis |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 5 |
| 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 Nov 2017 to primary completion in Jun 2018, 7 months.
Results were first posted in Aug 2023, 5 years 2 months after primary completion.
Of 42 interventional studies with no phase under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.