Rosacea, Scarring, Wrinkle
Conditions
Brief summary
Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array (MLA) Attachment
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.
Interventions
DEVICEExcel V™ Laser With Green Genesis
Subject(s) will receive treatments with a Cutera Excel V™ Laser
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Aesthetic Improvement Scale | 12 weeks post-final treatment | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Excel V™ Laser With Green Genesis Treatment with Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Excel V™ Laser With Green Genesis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Excel V™ Laser With Green Genesis | Global Aesthetic Improvement Scale | Right side of the face | 0.95 score on a scale | Standard Deviation 1.4 |
| Excel V™ Laser With Green Genesis | Global Aesthetic Improvement Scale | Left side of the face | 1.05 score on a scale | Standard Deviation 1.28 |