Trial Outcomes & Findings for Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions (NCT NCT05097157)
NCT ID: NCT05097157
Last Updated: 2022-06-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
30 day follow up
Results posted on
2022-06-09
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
|
79
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions
Baseline characteristics by cohort
| Measure |
Treatment With Device
n=79 Participants
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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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
78 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Algerian/French
|
1 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type I
|
0 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type II
|
32 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type III
|
43 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type IV
|
3 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type V
|
0 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type VI
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 day follow upPopulation: 6 subjects were considered complete but did not have satisfaction information from their 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.
Outcome measures
| Measure |
Treatment With Device
n=50 Participants
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.
|
|---|---|
|
Subject Satisfaction
Extremely Satisfied
|
7 Participants
|
|
Subject Satisfaction
Satisfied
|
21 Participants
|
|
Subject Satisfaction
Slightly Satisfied
|
15 Participants
|
|
Subject Satisfaction
Slightly Dissatisfied
|
4 Participants
|
|
Subject Satisfaction
Dissatisfied
|
2 Participants
|
|
Subject Satisfaction
Extremely Dissatisfied
|
1 Participants
|
PRIMARY outcome
Timeframe: 30 day follow upPopulation: 12 subjects were considered complete but did not have satisfaction information from their 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.
Outcome measures
| Measure |
Treatment With Device
n=44 Participants
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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|---|---|
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Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
Very Much Improved
|
1 Participants
|
|
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
Much Improved
|
8 Participants
|
|
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
Improved
|
27 Participants
|
|
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
No Change
|
8 Participants
|
|
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
Worsened
|
0 Participants
|
PRIMARY outcome
Timeframe: 90 day follow upPopulation: 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.
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.
Outcome measures
| Measure |
Treatment With Device
n=16 treatment areas
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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Subject Satisfaction
Extremely Satisfied
|
4 treatment areas
|
|
Subject Satisfaction
Satisfied
|
5 treatment areas
|
|
Subject Satisfaction
Slightly Satisfied
|
5 treatment areas
|
|
Subject Satisfaction
Slightly Dissatisfied
|
1 treatment areas
|
|
Subject Satisfaction
Dissatisfied
|
0 treatment areas
|
|
Subject Satisfaction
Extremely Dissatisfied
|
1 treatment areas
|
PRIMARY outcome
Timeframe: 90 day follow upPopulation: 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.
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.
Outcome measures
| Measure |
Treatment With Device
n=16 Treatment areas
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.
|
|---|---|
|
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
No Change
|
1 treatment areas
|
|
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
Very Much Improved
|
0 treatment areas
|
|
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
Much Improved
|
5 treatment areas
|
|
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
Improved
|
10 treatment areas
|
|
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
Worsened
|
0 treatment areas
|
Adverse Events
Treatment With Device
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment With Device
n=79 participants at risk
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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|---|---|
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Skin and subcutaneous tissue disorders
erythema
|
46.8%
37/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Edema
|
46.8%
37/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Pinpoint bleeding
|
41.8%
33/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
16.5%
13/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Dryness
|
16.5%
13/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Scabbing
|
11.4%
9/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Skin Textural Irregularity
|
11.4%
9/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
7.6%
6/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Pain/tenderness
|
7.6%
6/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Tightness
|
6.3%
5/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Itching
|
5.1%
4/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.8%
3/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.8%
3/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
3.8%
3/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Breakout
|
3.8%
3/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Streaking
|
5.1%
4/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Pain
|
3.8%
3/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Burn
|
5.1%
4/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Stabbing sensastion post pinpoint bleeding
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Eye disorders
Tearing
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Eye disorders
Eye twitch
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Rash/skin irritation
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
General disorders
Histamine
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Blanching
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Sensitivity
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Pinpoint dots
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Tingling
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Pustule
|
1.3%
1/79 • Subject data was collected throughout subject participation in the study, approximately 9 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
- Publication restrictions are in place
Restriction type: OTHER