Trial Outcomes & Findings for Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device (NCT NCT05096247)
NCT ID: NCT05096247
Last Updated: 2023-11-28
Results Overview
Subjects graded themselves on a scale ranging from "Worsened" to "Very Much Improved" at the follow up visit. The number of subjects who graded themselves as "Improved" was reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
12 week follow up
Results posted on
2023-11-28
Participant Flow
Participant milestones
| Measure |
Treatment With RF Device
Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face.
TempSure: This device is an RF device.
|
Treatment With IPL and RF Device
Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser.
TempSure: This device is an RF device.
Icon: This device works with IPL (Intense Pulsed Light) handpieces.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
35
|
|
Overall Study
COMPLETED
|
13
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device
Baseline characteristics by cohort
| Measure |
Treatment With RF Device
n=13 Participants
Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face.
TempSure: This device is an RF device.
|
Treatment With IPL and RF Device
n=35 Participants
Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser.
TempSure: This device is an RF device.
Icon: This device works with IPL (Intense Pulsed Light) handpieces.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
12 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type I
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type II
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type III
|
5 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type IV
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type V
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type VI
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 week follow upSubjects graded themselves on a scale ranging from "Worsened" to "Very Much Improved" at the follow up visit. The number of subjects who graded themselves as "Improved" was reported.
Outcome measures
| Measure |
Treatment With RF Device
n=13 Participants
Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face.
TempSure: This device is an RF device.
|
Treatment With IPL and RF Device
n=35 Participants
Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser.
TempSure: This device is an RF device.
Icon: This device works with IPL (Intense Pulsed Light) handpieces.
|
|---|---|---|
|
Number of Subjects Who Noticed Improvement
|
10 Participants
|
34 Participants
|
Adverse Events
Treatment With RF Device
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Treatment With IPL and RF Device
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment With RF Device
n=13 participants at risk
Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face.
TempSure: This device is an RF device.
|
Treatment With IPL and RF Device
n=35 participants at risk
Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser.
TempSure: This device is an RF device.
Icon: This device works with IPL (Intense Pulsed Light) handpieces.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
13/13 • Subjects had their adverse events collected throughout their participation in the study, approximately 12 months.
Subjects treated in the RF + IPL device group did not have these adverse events broken down by device.
|
14.3%
5/35 • Subjects had their adverse events collected throughout their participation in the study, approximately 12 months.
Subjects treated in the RF + IPL device group did not have these adverse events broken down by device.
|
|
Skin and subcutaneous tissue disorders
Edema
|
0.00%
0/13 • Subjects had their adverse events collected throughout their participation in the study, approximately 12 months.
Subjects treated in the RF + IPL device group did not have these adverse events broken down by device.
|
14.3%
5/35 • Subjects had their adverse events collected throughout their participation in the study, approximately 12 months.
Subjects treated in the RF + IPL device group did not have these adverse events broken down by device.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/13 • Subjects had their adverse events collected throughout their participation in the study, approximately 12 months.
Subjects treated in the RF + IPL device group did not have these adverse events broken down by device.
|
2.9%
1/35 • Subjects had their adverse events collected throughout their participation in the study, approximately 12 months.
Subjects treated in the RF + IPL device group did not have these adverse events broken down by device.
|
|
Skin and subcutaneous tissue disorders
Crusting
|
0.00%
0/13 • Subjects had their adverse events collected throughout their participation in the study, approximately 12 months.
Subjects treated in the RF + IPL device group did not have these adverse events broken down by device.
|
11.4%
4/35 • Subjects had their adverse events collected throughout their participation in the study, approximately 12 months.
Subjects treated in the RF + IPL device group did not have these adverse events broken down by device.
|
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