Trial Outcomes & Findings for Clinical Evaluation of Using Intense Pulsed Light for Improving the Appearance of Striae Distensae (NCT NCT02452359)
NCT ID: NCT02452359
Last Updated: 2020-11-03
Results Overview
Striae distensae appearance improvement by at least 1 point on the Global Aesthetic Improvement scale (GAIS) from photographs 3 months following the last treatment as determined by 3 blinded reviewers where 3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse, -2 = Much Worse and -3 = Very Much Worse.
TERMINATED
NA
54 participants
90 days following last IPL treatment
2020-11-03
Participant Flow
Each subject to receive IPL 580 nm treatment to striae distensae on either abdomen or thighs. Baseline photos taken of untreated treatment area.
Participant milestones
| Measure |
IPL 580 nm Treatment
Each subject to receive IPL applicator SR580 treatment of Striae Distensae either on the abdomen or thighs.
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
IPL 580 nm Treatment
Each subject to receive IPL applicator SR580 treatment of Striae Distensae either on the abdomen or thighs.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
The baseline photographs were not evaluated.
Baseline characteristics by cohort
| Measure |
Treatment Group
n=54 Participants
Group receiving treatment with Venus Versa IPL energy
Venus Versa: The Venus Versa system consists of a console and 4 detachable applicators that deliver optical energy in the form of Intense Pulsed Light to the patient skin. The intense pulsed light lamp delivers non-coherent light distributed over a range of wavelengths from 500 nm to 1200 nm. Different filters are embedded in the different applicators so that each applicator can deliver the desired spectrum according to the indications to be treated.In this study, the IPL applicator SR580 will be evaluated for the treatment of Striae Distensae, depending on the patient's skin type.
IPL gel: water based gel used to protect the skin during light based treatments. Is also commonly used during ultrasound treatments.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=54 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
|
Sex/Gender, Customized
Male
|
1 Participants
n=54 Participants
|
|
Sex/Gender, Customized
Female
|
32 Participants
n=54 Participants
|
|
Sex/Gender, Customized
Unknown
|
21 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
25 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
unknown
|
22 Participants
n=54 Participants
|
|
Baseline photograph of treatment area
|
0 Participants
The baseline photographs were not evaluated.
|
PRIMARY outcome
Timeframe: 90 days following last IPL treatmentPopulation: The primary outcome measure is not reported as data not collected.
Striae distensae appearance improvement by at least 1 point on the Global Aesthetic Improvement scale (GAIS) from photographs 3 months following the last treatment as determined by 3 blinded reviewers where 3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse, -2 = Much Worse and -3 = Very Much Worse.
Outcome measures
Outcome data not reported
Adverse Events
IPL 580 nm Treatment
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
- Publication restrictions are in place