Trial Outcomes & Findings for Post Market Clinical Follow Up Study to Collect Additional Data and Imaging (NCT NCT04881058)
NCT ID: NCT04881058
Last Updated: 2023-06-27
Results Overview
Three blinded independent reviewers will perform a photographic evaluation in which they will be asked to identify pre-treatment images when compared to post treatment images. The percentage of photographs that were correctly identified as either baseline photographs or photographs taken at the 3 month follow up will be reported. Identifying whether the photograph was taken at the baseline vs. 3 month follow up was only done at the 3 month follow up point.
COMPLETED
NA
10 participants
3 month follow up
2023-06-27
Participant Flow
Participant milestones
| Measure |
PicoSure Device
The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles.
RF Non-Invasive Treatment: Self-controlled single-arm group using the PicoSure device.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Market Clinical Follow Up Study to Collect Additional Data and Imaging
Baseline characteristics by cohort
| Measure |
PicoSure Device
n=10 Participants
The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles.
RF Non-Invasive Treatment: Self-controlled single-arm group using the PicoSure device.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type I
|
0 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type II
|
4 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type III
|
5 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type IV
|
1 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type V
|
0 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type VI
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 month follow upThree blinded independent reviewers will perform a photographic evaluation in which they will be asked to identify pre-treatment images when compared to post treatment images. The percentage of photographs that were correctly identified as either baseline photographs or photographs taken at the 3 month follow up will be reported. Identifying whether the photograph was taken at the baseline vs. 3 month follow up was only done at the 3 month follow up point.
Outcome measures
| Measure |
PicoSure Device
n=30 photographs
The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles.
RF Non-Invasive Treatment: Self-controlled single-arm group using the PicoSure device.
|
|---|---|
|
Correct Identification of Baseline Photographs vs. Photographs Taken 3 Months Post Last Treatment
|
80 % of photos correctly identified
|
Adverse Events
PicoSure Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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