Skin Aging
Conditions
Brief summary
The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.
Detailed description
The purpose of this investigation is to evaluate erbium laser devices for dermatological cosmetic procedures. Each subject will undergo up to 6 treatment sessions, with scheduled time-points for follow-up visits. The Investigator determines the number of treatments. Subjects may be treated on there face, neck, chest or other body areas as deemed appropriate by the Investigator. At each visit, the treated areas will be clinically evaluated for side effects and will also have photographs taken of their treated areas. Subjects will be asked to complete a self-assessment questionnaire at different time points throughout their study participation.
Interventions
DEVICEErbium laser
Erbium laser treatment. Each subject will undergo up to 6 treatment sessions
Sponsors
Palomar Medical Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy male and female Adults (18 years or older). * Subjects who can read, understand, and sign the Informed Consent Form. * Subjects willing and able to comply with all study requirements.
Exclusion criteria
* Subjects with active localized or systemic infections. * Immunocompromised subjects. * Subjects with coagulation disorder. * History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs). * Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study). * In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits. * Use of Accutane® within the past 6 months. * Subjects with a history of radiation therapy to the treatment area. * Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments. * Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale. | participants at three months | To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia. | participants at three months | To assess reductions in pigmented lesions and dyschromia, blinded evaluators were asked to assess pre-treatment and post-treatment photographs. The blinded evaluators were asked to grade percent improvement for pigmentation using a 0 to 10 scale (0=none and 10=severe) and the following quartile improvement scale: 1=1-24%, 2=25-49%, 3=50-74% and 4=75-100%. The blinded-evaluator scores were tabulated and analyzed in order to assess the effects. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erbium Laser Each subject will undergo a minimum of 1 treatment with 5 scheduled follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed. | 124 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 27 |
Baseline characteristics
| Characteristic | Erbium Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants |
| Age Continuous | 55 years STANDARD_DEVIATION 8.11 |
| Region of Enrollment United States | 124 participants |
| Sex: Female, Male Female | 116 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 124 / 124 |
| serious Total, serious adverse events | 0 / 124 |
Outcome results
Primary
Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.
To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction.
Time frame: participants at three months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erbium Laser | Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale. | 124 Participants |
Secondary
Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.
To assess reductions in pigmented lesions and dyschromia, blinded evaluators were asked to assess pre-treatment and post-treatment photographs. The blinded evaluators were asked to grade percent improvement for pigmentation using a 0 to 10 scale (0=none and 10=severe) and the following quartile improvement scale: 1=1-24%, 2=25-49%, 3=50-74% and 4=75-100%. The blinded-evaluator scores were tabulated and analyzed in order to assess the effects.
Time frame: participants at three months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erbium Laser | Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia. | 124 Participants |