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The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erbium laser | Device | Erbium laser treatment. Each subject will undergo up to 6 treatment sessions |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | participants at three months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic Laser & Cosmetic Dermatology | San Diego | California | 92130 | United States | ||
| Palomar Medical Technologies, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erbium Laser | Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Participants | participants at three months |
|
Minimum of 3 months post treatment, or until adverse events resolve
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erbium Laser | Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Petechiae | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Regulatory Affairs | Palomar Medical Technologies, Inc. | 781-993-2414 | stimberlake@palomarmedical.com |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| participants at three months |
| Burlington |
| Massachusetts |
| 01803 |
| United States |
| Brooke Seckel, MD | Concord | Massachusetts | 01742 | United States |
| Skin & Laser Surgery Center | Nashua | New Hampshire | 03060 | United States |
| The University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | Posted | Number | Participants | participants at three months |
|
|
|
| 0 |
| 124 |
| 124 |
| 124 |
|
| Edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
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| Bleeding | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
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| Oozing | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
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| Skin Texture Changes | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
|
| Bronzing | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
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| Sloughing | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
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| Shrinkage | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
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| Increased Sensitivity | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
|
| Crusting | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient side effects all resolved. |
|
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