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Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. Up to 120 subjects will be enrolled at multiple study centers. Subjects may receive up to 5 treatments for a wide array of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Device | Experimental | Subjects received up to 5 treatments with the device, spaced 4 weeks apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potenza | Device | Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction | Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied. | 30 day follow up |
| Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image. | 30 day follow up |
| Subject Satisfaction | Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied. | 90 day follow up |
| Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image. | 90 day follow up |
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Inclusion Criteria:
Exclusion Criteria:
Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
The subject has physical problems such as cardiovascular disorders.
The subject has a pacemaker.
The subject had previous use of gold thread skin rejuvenation.
The subject has skin infections.
The subject has any of the following conditions:
Subjects with electronic implants such as cardiac defibrillator. It may interfere with operation of electronic implants or damage the implants, causing risks.
The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Civiok | Cynosure, Inc. | Study Director |
| Sean Doherty | Cynosure, Inc. | Principal Investigator |
| Robert Weiss | Maryland Dermatology Laser, Skin, & Vein Institute, LLC | Principal Investigator |
| Emil Tanghetti | Center for Dermatology and Laser Surgery | Principal Investigator |
| David McDaniel | McDaniel Institute of Anti-Aging Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology and Laser Surgery | Sacramento | California | 95819 | United States | ||
| Maryland Dermatology Laser, Skin, & Vein Institute, LLC. |
| 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 | Treatment With Device | Subjects received up to 5 treatments with the device, spaced 4 weeks apart. Potenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Device | Subjects received up to 5 treatments with the device, spaced 4 weeks apart. Potenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | One subject was 72 years old and was given permission to enroll in the study per the investigator's discretion. |
| 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 | Subject Satisfaction | Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied. | 6 subjects were considered complete but did not have satisfaction information from their 30 day follow up. | Posted | Count of Participants | Participants | 30 day follow up |
|
Subject data was collected throughout subject participation in the study, approximately 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 | Treatment With Device | Subjects received up to 5 treatments with the device, spaced 4 weeks apart. Potenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body. |
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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 | |
|---|---|---|---|---|
| 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 | Dec 7, 2020 | Apr 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D057896 | Striae Distensae |
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Hunt Valley |
| Maryland |
| 21030 |
| United States |
| Cynosure | Westford | Massachusetts | 01886 | United States |
| McDaniel Institute of Anti-Aging Research | Virginia Beach | Virginia | 23462 | United States |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| FitzPatrick Skin Type | Measure Description: The Fitzpatrick Skin Score is used to determine skin color. It is a numerical system that classifies skin into six types (Type I, Type II, Type III, Type IV, Type V and Type VI) based on the numerical score achieved (ranging from 0 to 36). The lower the score (and skin type number), the fairer the skin. The higher the score (and skin type number), the more deeply pigmented the skin is. The scale used is cited in the reference section | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image. | 12 subjects were considered complete but did not have satisfaction information from their 30 day follow up. | Posted | Count of Participants | Participants | 30 day follow up |
|
|
|
| Primary | Subject Satisfaction | Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied. | 40 subjects did not complete the 90 day follow up for the subject satisfaction However, subjects who completed at least their 30 day follow up were considered complete. 1 subject had 2 different treatment areas treated and had a satisfaction score taken for both treatment areas. | Posted | Number | treatment areas | 90 day follow up | treatment areas | treatment areas |
|
|
|
| Primary | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image. | 41 subjects did not complete the 90 day follow up for the CGAIS. However, subjects who completed at least their 30 day follow up were considered complete. 1 subject had 2 different treatment areas treated and had a CGAIS taken for both treatment areas. | Posted | Number | treatment areas | 90 day follow up | Treatment areas | Treatment areas |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| 37 |
| 79 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pinpoint bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dryness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scabbing | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Textural Irregularity | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pain/tenderness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tightness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Breakout | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Streaking | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Burn | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Stabbing sensastion post pinpoint bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tearing | Eye disorders | Systematic Assessment |
|
| Eye twitch | Eye disorders | Systematic Assessment |
|
| Hypopigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash/skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Histamine | General disorders | Systematic Assessment |
|
| Blanching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sensitivity | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pinpoint dots | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pustule | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| No Change |
|
| Worsened |
|
| Title | Measurements |
|---|---|
|
| Slightly Dissatisfied |
|
| Dissatisfied |
|
| Extremely Dissatisfied |
|
| Title | Measurements |
|---|---|
|
| No Change |
|
| Worsened |
|