Rejuvenation
Conditions
Brief summary
Single-center study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation.
Detailed description
A single-center prospective, open-label uncontrolled exploratory study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation. Subjects will receive laser treatments, and will be followed at 12 weeks post-final treatment. In addition, after each treatment, subjects will complete a 3 day post treatment phone follow-up.
Interventions
DEVICEenLighten Laser
Dual-pulse duration laser for the treatment of skin rejuvenation
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Female or Male, 18 to 75 years of age (inclusive). * Fitzpatrick Skin Type I - VI. * Desires photo-rejuvenation of the skin or improvement in the appearance of acne scarring. * Subject has visible signs of acne scarring or moderate sun-damaged and/or aging skin in the treatment area with visible areas acne lesions and scars, fine rhytides, lentigines or pigmentation, diffused redness erythema and skin texture * Subject must be able to read, understand and sign the Informed Consent Form. * Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions. * Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period. * Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes. * Agree to not undergo any other procedure(s), including injectable agents, for skin rejuvenation during the study and has no intention of having such procedures performed during the course of the study. * 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.
Exclusion criteria
* Participation in a clinical trial of another drug, or device administered to the target area, during the study. * 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. * Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation. * History of malignant tumors in the target area. * Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles. * Pregnant and/or breastfeeding. * Having an infection, dermatitis or a rash in the treatment area. * Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension. * History of keloid scarring, hypertrophic scarring or of abnormal wound healing. * History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications per investigator's discretion. * History of vitiligo, eczema, or psoriasis. * History of connective tissue disease, such as systemic lupus erythematosus or scleroderma. * History of seizure disorders due to light. * Any use of medication that is known to increase sensitivity to light according to Investigator's discretion. * 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 * History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. * Systemic use of retinoid, such as isotretinoin, as applicable, within 6 months of study participation. * Topical use of retinoid, such as isotretinoin, as applicable, on the treatment area within 1 month of participation. * Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus. * Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study. * Current smoker or history of smoking within 6 months of study participation. * 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 as Assessed by the Investigator (Physician's Global Assessment of Improvement). | 12 weeks post-final treatment, an average of 4 months | Degree of improvement in the treated area at 12 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant Clearing 3=Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational Enlighten Device Laser treatment for facial skin rejuvenation with the experimental enLighten Laser | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Investigational Enlighten Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 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 | 2 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Degree of Improvement as Assessed by the Investigator (Physician's Global Assessment of Improvement).
Degree of improvement in the treated area at 12 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant Clearing 3=Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing
Time frame: 12 weeks post-final treatment, an average of 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Enlighten Device | Degree of Improvement as Assessed by the Investigator (Physician's Global Assessment of Improvement). | 1.7 score on a scale | Standard Deviation 1.5 |