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

Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera Excel V™ Laser With Green Genesis and a Micro-Lens Array Attachment as Compared to the Standard-of-care With an Excel V™ Laser

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

Study Overview

• Status: Completed
• Conditions: Rosacea; Wrinkle; Scarring
• Intervention / Treatment: Device: Excel V™ Laser With Green Genesis

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Brisbane, California, United States, 94005
      • Cutera Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subject must be able to read, understand and sign the Informed Consent 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 post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.

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, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.
7. Hypersensitivity 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Subject(s) will receive treatments with a Cutera Excel V™ Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks post-final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement #1 of device Adverse Effects (AE)	Safety of the Cutera excel V laser with Green Genesis and Micro-Lens Array (MLA) Attachment as assessed by frequency and severity (0=none, 1=mild, 2=moderate, or 3=severe) of device related adverse events as reported up to the 12 week follow-up visit.	through study completion, an average of 1 year
Measurement #2 of device Adverse Effects (AE)	Safety of the Cutera excel V laser with Micro-Lens Array attachment as assessed by frequency and severity (0=none, 1=mild, 2=moderate or 3=severe) of device adverse events as reported up to the 12 week follow-up visit.	through study completion, an average of 1 year
Measurement #3 of skin quality	Efficacy of the Cutera excel V laser with Green Genesis to diffuse facial redness and/or improve dyschromia (pigment) as compared to the Standard-of-Care (SOC) procedure using Excel V, as assessed by the study investigator at 2-4 weeks after the 3rd laser treatment visit and at the 12 week follow-up visit, using Skin Quality Rating Scale (1-10): for Radiance, Smoothness, Pigmentation, Erythema and Pore size.	2 to 4 weeks after third treatment and12 weeks post-final treatment
Measurement #4 of wrinkles	Efficacy of the Cutera excel V laser with the Micro-Lens Array to treat fine lines and skin texture, as compared to the Standard-of-Care (SOC) procedure using Excel V, as assessed by the study investigator at 2-4 weeks after the 3rd laser treatment visit and at the 12 week follow-up visit using the Fitzpatrick Wrinkle Classification System (FWCS): (1-3=fine wrinkles, 4-6=moderate depth & moderate number of lines, and 7-9=severe depth & numerous lines)	2 to 4 weeks after third treatment and12 weeks post-final treatment
Measurement #4 of acne scarring	Efficacy of the Cutera excel V laser with the Micro-Lens Array to improve acne scar severity as compared to the Standard-of-Care (SOC) procedure using Excel V, as assessed by the study investigator at 2-4 weeks after the 3rd laser treatment visit and at the 12 week follow-up visit, using Acne Scar Assessment Scale (ASAS): (+1=clear, +2=very mild, +3=mild, +4=moderate, and 5=severe)	2 to 4 weeks after third treatment and12 weeks post-final treatment

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Stephen Ronan, MD, Cutera Research Center

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): June 22, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: C-17-EV12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No