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The purpose of this study is to evaluate the effectiveness and safety of two laser systems for improvement of lentigines on the hands.
The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of two laser systems for the treatment of lentigines (liver spots, age spots, or dark sun spots) on the hands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlighten Laser | Experimental | 12 subjects will receive treatment the Enlighten laser. |
|
| Excel V Laser | Active Comparator | 12 subjects will receive treatment with the Excel V laser. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlighten Laser | Device |
| ||
| Excel V Laser |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers. | 4 weeks post-final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment Score of the Overall Appearance of the Hands | Degree of improvement in the overall appearance of the hands as assessed by blinded reviewers using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change Higher scores indicate better outcomes | 4 weeks post final treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Stankiewicz, MD FAAD | DuPage Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DuPage Medical Group | Naperville | Illinois | 60563 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Excel V Laser | 12 subjects will be enrolled in the Excel V group, . |
| FG001 | Enlighten Laser | 12 subjects will be enrolled in the Enligthen group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Excel V Laser | 12 subjects will be enrolled in the Excel V group |
| BG001 | Enlighten Laser | 12 subjects will be enrolled in the Enlighten group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers. | Study terminated prior to outcome data collected due to company change in priorities. | Posted | 4 weeks post-final treatment |
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4 weeks post final treatment, up to 17 weeks
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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 | Excel V Laser | 12 subjects will be enrolled in the Excel V group | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-656-9612 | mdoucette@cutera.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2016 | Mar 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007911 | Lentigo |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
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| Physician's Global Assessment Score of Skin Texture of the Hands | Degree of improvement in the Skin Texture of the hands as assessed using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change. Higher scores indicate better outcomes | 4 weeks post final treatment |
| Subject Satisfaction | Subject-completed questionnaire to rate their level of satisfaction with the laser treatment outcome | 4 weeks post final treatment |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Participants |
|
| Secondary | Physician's Global Assessment Score of the Overall Appearance of the Hands | Degree of improvement in the overall appearance of the hands as assessed by blinded reviewers using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change Higher scores indicate better outcomes | 1 subject was lost to follow up in the Excel V group | Posted | Mean | Standard Deviation | score on a scale | 4 weeks post final treatment |
|
|
|
| Secondary | Physician's Global Assessment Score of Skin Texture of the Hands | Degree of improvement in the Skin Texture of the hands as assessed using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change. Higher scores indicate better outcomes | 1 subject was lost to follow up in the Excel V group | Posted | Mean | Standard Deviation | score on a scale | 4 weeks post final treatment |
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|
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| Secondary | Subject Satisfaction | Subject-completed questionnaire to rate their level of satisfaction with the laser treatment outcome | 1 subject was lost to follow up in the Excel V group | Posted | Count of Participants | Participants | 4 weeks post final treatment |
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|
|
| 12 |
| 0 |
| 12 |
| 6 |
| 12 |
| EG001 | Enlighten Laser | 12 subjects will be enrolled in the Enlighten group. | 0 | 12 | 0 | 12 | 9 | 12 |
| Darkening of vessel | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Neutral |
|