Wrinkle, Fine Lines, Crepey Skin, Acne Scars, Acne, Enlarged Pores, Stretch Marks, Loose Skin
Conditions
Brief summary
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.
Interventions
DEVICEPotenza
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.
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* A healthy, non-smoking male or female between the age of 18-55 years old. * Fitzpatrick skin type I to VI. * Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study. * Understands and accepts the obligation and is logistically able to be present for all visits. * Is willing to comply with all requirements of the study and sign the informed consent document.
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: * Diabetes * Epilepsy * Acute disease * Dermatitis * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 30 day follow up | 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. |
| Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | 30 day follow up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 79 |
| Total | 79 |
Baseline characteristics
| Characteristic | Treatment With Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type I | 0 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type II | 32 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type III | 43 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type IV | 3 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type V | 0 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type VI | 1 Participants |
| Race/Ethnicity, Customized African American | 1 Participants |
| Race/Ethnicity, Customized Algerian/French | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 72 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 79 |
| other Total, other adverse events | 37 / 79 |
| serious Total, serious adverse events | 0 / 79 |
Outcome results
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.
Time frame: 30 day follow up
Population: 12 subjects were considered complete but did not have satisfaction information from their 30 day follow up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Device | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | Very Much Improved | 1 Participants |
| Treatment With Device | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | Much Improved | 8 Participants |
| Treatment With Device | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | Improved | 27 Participants |
| Treatment With Device | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | No Change | 8 Participants |
| Treatment With Device | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | Worsened | 0 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.
Time frame: 90 day follow up
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment With Device | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | Very Much Improved | 0 treatment areas |
| Treatment With Device | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | Much Improved | 5 treatment areas |
| Treatment With Device | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | Improved | 10 treatment areas |
| Treatment With Device | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | No Change | 1 treatment areas |
| Treatment With Device | Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | Worsened | 0 treatment areas |
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.
Time frame: 30 day follow up
Population: 6 subjects were considered complete but did not have satisfaction information from their 30 day follow up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Device | Subject Satisfaction | Extremely Satisfied | 7 Participants |
| Treatment With Device | Subject Satisfaction | Satisfied | 21 Participants |
| Treatment With Device | Subject Satisfaction | Slightly Satisfied | 15 Participants |
| Treatment With Device | Subject Satisfaction | Slightly Dissatisfied | 4 Participants |
| Treatment With Device | Subject Satisfaction | Dissatisfied | 2 Participants |
| Treatment With Device | Subject Satisfaction | Extremely Dissatisfied | 1 Participants |
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.
Time frame: 90 day follow up
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment With Device | Subject Satisfaction | Extremely Satisfied | 4 treatment areas |
| Treatment With Device | Subject Satisfaction | Satisfied | 5 treatment areas |
| Treatment With Device | Subject Satisfaction | Slightly Satisfied | 5 treatment areas |
| Treatment With Device | Subject Satisfaction | Slightly Dissatisfied | 1 treatment areas |
| Treatment With Device | Subject Satisfaction | Dissatisfied | 0 treatment areas |
| Treatment With Device | Subject Satisfaction | Extremely Dissatisfied | 1 treatment areas |