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This is a prospective, open label, single-center clinical study to collect safety and efficacy data on the Elite iQ workstation. The intended use of the Elite iQ device used in this study is for the treatment of hair removal, pseudo folliculitis barbae, and benign vascular and pigmented lesions.
Up to 20 subjects will be enrolled at up to 1 study center. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments on multiple areas of the body such as, but not limited to, the face, legs, and arms. All subjects will be required to return a follow-up visit at 30 - 90 days after the final treatment in each treatment area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elite IQ Laser | Experimental | The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF Non-Invasive Treatment | Device | Self-controlled single-arm group using the Elite IQ device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blinded Evaluation of Pre-treatment Images vs. Follow up Images to Determine Which Image Was Taken Pre-treatment vs. at the Follow up. | Blind identification of pre-treatment images vs. 60 day follow up images. It is performed by independent reviewers. The outcome will be reported as a percentage of photographs identified correctly. | 60 day (+/- 30 days) post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Principle Investigator Assessment Using the Global Aesthetic Improvement Scale (PGAIS) | Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 60 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse." This is the count of the number of subjects who the physician graded a 3 or higher. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Civiok | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic Carmel Valley | San Diego | California | 92130 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31896400 | Result | Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Elite IQ Laser | The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms. RF Non-Invasive Treatment: Self-controlled single-arm group using the Elite IQ device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Elite IQ Laser | The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms. RF Non-Invasive Treatment: Self-controlled single-arm group using the Elite IQ device |
| 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 | Blinded Evaluation of Pre-treatment Images vs. Follow up Images to Determine Which Image Was Taken Pre-treatment vs. at the Follow up. | Blind identification of pre-treatment images vs. 60 day follow up images. It is performed by independent reviewers. The outcome will be reported as a percentage of photographs identified correctly. | Three subjects had an extra treatment area treated, and were graded for each separate treatment area, so the total number of treatment areas graded was 23 (23 photos were analyzed). Each photo was graded by 3 individual graders, for a total of 69 photos being analyzed. The average percentage of photographs identified correctly of these 3 graders is reported. | Posted | Mean | Standard Deviation | % of photos correctly identified | 60 day (+/- 30 days) post last treatment | Photos | Photos |
|
All adverse events were collected and resolved during the time period of when the study started to the final follow up date (6 months post last treatment, up to a total of 9 months)
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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 | Elite IQ Laser | The Elite IQ will be used on multiple areas of the body such as, but not limited to, the face, legs, and arms. RF Non-Invasive Treatment: Self-controlled single-arm group using the Elite IQ device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | (978) 256-4200 | jamie.trimper@cynosure.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 | Oct 30, 2020 | May 22, 2023 | Prot_SAP_001.pdf |
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| 60 day (+/- 30 days) post last treatment |
| Subject Satisfaction | Subject satisfaction rates at the 60 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied. This is the count of the number of subjects who graded themselves a 4 or higher. | 60 day (+/- 30 days) post last treatment |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| FitzPatrick Skin Type | Count of Participants | Participants |
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|
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| Secondary | Principle Investigator Assessment Using the Global Aesthetic Improvement Scale (PGAIS) | Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 60 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse." This is the count of the number of subjects who the physician graded a 3 or higher. | Posted | Count of Participants | Participants | 60 day (+/- 30 days) post last treatment |
|
|
|
| Secondary | Subject Satisfaction | Subject satisfaction rates at the 60 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied. This is the count of the number of subjects who graded themselves a 4 or higher. | Posted | Count of Participants | Participants | 60 day (+/- 30 days) post last treatment |
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| 0 |
| 20 |
| 0 |
| 20 |
| 20 |
| 20 |
| Crusting | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypopigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.