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| ID | Type | Description | Link |
|---|---|---|---|
| C-13-LPS03 | Other Identifier | Cutera |
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The purpose of this study is to determine whether picosecond laser is effective in the treatment of age (sun) spots.
The purpose of this study is to evaluate the safety and efficacy of Cutera Picosecond Q-Switched Nd:YAG 1064 and/or 532 nm laser in the treatment of benign pigmented lesions on the hands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Picosecond QS Nd:YAG Laser | Experimental | Laser Treatment with Investigational Device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Picosecond QS Nd:YAG Laser | Device | Up to 2 laser treatments delivered 6 weeks apart |
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| Measure | Description | Time Frame |
|---|---|---|
| Median VAS Improvement Score as Assessed by Blinded Physician Reviewers | Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved. | 12 weeks post- final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Improvement Score >/=1 | Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores >/=1 indicate improvement. | 12 weeks post- final treatment |
| Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lourdes Moldre, NP | Cutera Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cutera Research Center | Brisbane | California | 94005 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart |
| 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 | Median VAS Improvement Score as Assessed by Blinded Physician Reviewers | Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved. | Based on blinded photographic assessments of 20 subjects. Scores >/=1 indicate clearing. | Posted | Median | 95% Confidence Interval | units on a scale | 12 weeks post- final treatment |
|
|
Adverse Event Data was collected immediately post treatment, 3 days and 14 days after treatment as well as 6, 12, and 24 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 | Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema (swelling) | Skin and subcutaneous tissue disorders | Edema | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Department | Cutera, Inc | 1-888-428-8372 | gweiss@cutera.com |
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Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants, as measured by spot Improvement: 3=Very Much Improved, 2=Much Improved, 1=Improved, and 0=No Change. |
| 12 weeks post- final treatment |
| Mean Pain Score Associated With Laser Treatments | Subjects graded the level of pain associated with each laser treatment, using a 0-10 scale where 0=no pain and 10=worse possible pain, then averaged to get the mean across the treatments. | During treatments |
| Percent of Subjects With Post-treatment Adverse Event | During study duration 0-6 months. |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Percent of Participants With Improvement Score >/=1 | Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores >/=1 indicate improvement. | Posted | Number | percent of participants | 12 weeks post- final treatment |
|
|
|
| Secondary | Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines | Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants, as measured by spot Improvement: 3=Very Much Improved, 2=Much Improved, 1=Improved, and 0=No Change. | Based on subject questionnaires, 90% of subjects reported improvement (clearing) in benign pigmented lesions at 12 weeks post- final treatment. Scores > or =1 indicate improvement. | Posted | Number | percent of participants | 12 weeks post- final treatment |
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|
| Secondary | Mean Pain Score Associated With Laser Treatments | Subjects graded the level of pain associated with each laser treatment, using a 0-10 scale where 0=no pain and 10=worse possible pain, then averaged to get the mean across the treatments. | Posted | Mean | Full Range | units on a scale | During treatments |
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| Secondary | Percent of Subjects With Post-treatment Adverse Event | Posted | Number | percent of participants | During study duration 0-6 months. |
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| 0 |
| 20 |
| 20 |
| 20 |
| Erythema (Redness) | Skin and subcutaneous tissue disorders | Erythema | Systematic Assessment |
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| Purpura (Bruising) | Skin and subcutaneous tissue disorders | Purpura | Systematic Assessment |
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| Blisters | Skin and subcutaneous tissue disorders | Blisters | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Eczema | Systematic Assessment |
|
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