Photoaging, Skin Pigment
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEexcel V Laser
excel V Laser Genesis procedure utilizing 1064 nm laser
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female or Male, 35 to 55 years of age (inclusive). 2. Fitzpatrick Skin Type I - IV. 3. Desires non-invasive and non-ablative treatment of skin-aging or photo-rejuvenation of the skin. 4. Have signs of moderate skin aging, including presence of mild to moderate rhytides around eyes and upper lip, multiple lentigines, diffuse erythema or telangiectasia, and a score between 4 and 7 (inclusive) on the Fitzpatrick Wrinkle Classification Scale. 5. Subject must be able to read, understand and sign the Informed Consent Form. 6. Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions. 7. Willing to have very limited sun exposure and use an approved sunscreen of SPF 30 or higher on the treatment area every day for the duration of the study, including the follow-up period. 8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes. 9. Agree to not undergo any other procedure(s) for skin rejuvenation during the study, including but not limited to chemical peel, laser and light based device treatment, and home-use device treatment. 10. Agree to not undergo any injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler during the study. 11. Post-menopausal or 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, and no plans to become pregnant or to father a child for the duration of the study.
Exclusion criteria
1. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study. 2. Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery. 3. Prior injection to the face of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation, as applicable. 4. Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation. 5. Use of topical medications on the face, such as antibiotics, benzoyl peroxide, retinoids (isotretinoin), corticosteroids, hydroquinone, or products containing dihydroxyacetone or alpha-hydroxy with concentration \> 8%, within 1 month of participation. 6. History of malignant tumors in the target area. 7. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles. 8. Pregnant and/or breastfeeding. 9. Having an infection, dermatitis or a rash in the treatment area. 10. Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension. 11. Suffering from coagulation disorders, or taking prescription anticoagulation medication which might make study participation unsafe according to Investigator's discretion. 12. History of keloid scarring, hypertrophic scarring or of abnormal wound healing. 13. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. 14. History of vitiligo, eczema, or psoriasis. 15. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma. 16. History of seizure disorders due to light. 17. Any use of medication that is known to increase sensitivity to light according to Investigator's discretion. 18. 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. 19. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer. 20. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. 21. Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus. 22. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study. 23. Current smoker or history of smoking within 6 months of study participation. 24. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Improvement Rating at 12 Weeks Post-final Treatment | 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( |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Excel V Laser Treatment with the excel V Laser Genesis procedure utilizing 1064 nm laser | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Excel V Laser |
|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 7.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 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 | 14 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 16 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excel V Laser | Degree of Improvement Rating at 12 Weeks Post-final Treatment | 1.4 score on a scale | Standard Deviation 0.8 |