ClinicalTrials.gg
CompletedNCT03424304Updated Aug 23, 2023Results posted

Evaluation of Cutera Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment

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

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

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.

Enrollment
110th of 137
20 · median 78
Started
2017
with 16 others
No phase
23 of 145
4 open now
Registered
97th of 145
by date

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.

Rosacea

233 studies on the registry are indexed under Rosacea; 23 are open to participants now.

Browse Rosacea studies →

Open to participants now

8 of the 145 studies in Rosacea with a site in United States are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

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 →

Who these studies take

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.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 145 studies in Rosacea with a site in United States, or all of them as a file.
02

Study summary

Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array (MLA) Attachment

Read the detailed description

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.

03

Conditions studied

  • Wrinkle
  • Rosacea
  • Scarring

Browse trials for

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. Subject must be able to read, understand and sign the Form.
  2. Female or Male, 18 to 65 years of age (inclusive).
  3. Fitzpatrick Skin Type I - VI (Appendix 4).
  4. Must be willing to have Cutera excel V laser treatments with MLA and/or Green Genesis (532 nm) and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions.
  5. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.
  6. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation (educational and/or marketing), publications, and any additional marketing purposes.
  7. Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the face during the study and has no intention of having such procedures performed during the course of the study.
  8. For female subjects: not pregnant or lactating and is either , surgically sterilized, or using a medically acceptable form of at least 3 months prior to enrollment and during the entire course of the study.

Exclusion criteria

Exclusion Criteria:

  1. Participation in a clinical trial of another drug, or device administered to the treatment area, within 3 months prior to enrollment or during the study.
  2. Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser procedures, facial fillers, toxins and those used for general aesthetic correction.
  3. Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity.
  4. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
  5. Pregnant and/or breastfeeding, or planning to become pregnant.
  6. Significant concurrent illness, such as diabetes mellitus, /immune deficiency disorders (including infection or AIDS) or using immunosuppressive medication.
  7. to light exposure.
  8. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.
  9. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.
  10. Has a history of squamous cell carcinoma or melanoma in the treatment area.
  11. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
  12. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment.
  13. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
  14. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
  15. History of pigmentary disorders, particularly tendency for hyper- or hypo- pigmentation, or any that are considered not acceptable by the study investigator.
  16. Has used oral isotretinoin (Accutane or therapeutic vitamin A supplements of equal to, or greater than 10,000 units per day) within 12 months of initial treatment or plans on using during the course of the study (note: skin must regain its normal degree of moisture prior to treatment, e.g. lack of noticeable skin flaking and peeling).
  17. Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to refrain from tanning during the study.
  18. Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment.
  19. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.
Terms in these criteria, in plain language(6)

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.

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.

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).

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Excel V™ Laser With Green Genesis

    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

Interventions

  • DeviceExcel V™ Laser With Green Genesis

    Subject(s) will receive treatments with a Cutera Excel V™ Laser

06

What researchers measure

Primary outcomes

  1. 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

07

Results

Posted Aug 23, 2023

Participant flow

Participant flow — Overall Study
MilestoneExcel V™ Laser With Green Genesis
Started20
Completed19
Not completed1

Outcome measures

PrimaryGlobal 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
Reported as:
Mean · score on a scale
Global Aesthetic Improvement Scale
score on a scaleExcel V™ Laser With Green Genesis
Right side of the face0.95 ± 1.40
Left side of the face1.05 ± 1.28

Adverse events

Collected over Up to 12 weeks post-final treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Excel V™ Laser With Green Genesis0/20 (0%)0/20 (0%)20/20 (100%)
Most frequent other events
Most frequent other events
EventExcel V™ Laser With Green Genesis
ErythemaSkin and subcutaneous tissue disorders20/20
EdemaSkin and subcutaneous tissue disorders12/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Excel V™ Laser With Green Genesis
<=18 years0
Between 18 and 65 years20
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Excel V™ Laser With Green Genesis
Female16
Male4
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Excel V™ Laser With Green Genesis
American Indian or Alaska Native1
Asian5
Native Hawaiian or Other Pacific Islander0
Black or African American0
White14
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Cutera Research Center
    Brisbane, California 94005, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Dec 13, 2017
First posted
Feb 7, 2018
StartActual
Nov 6, 2017
Primary completionActual
Jun 22, 2018
CompletionActual
Jun 30, 2018
Results first posted
Aug 23, 2023
Last update
Aug 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03424304
Lead sponsor
Cutera Inc.
Responsible party
Sponsor
First posted
Feb 7, 2018
Start date
Nov 6, 2017
Primary completion
Jun 22, 2018
Completion
Jun 30, 2018
Results posted
Aug 23, 2023
Last update
Aug 23, 2023

Study contacts

Stephen Ronan, MD
principal investigator · Cutera Research Center

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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