Trial Outcomes & Findings for An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring (NCT NCT05674292)
NCT ID: NCT05674292
Last Updated: 2023-09-13
Results Overview
Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
2 weeks
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
Erchonia Violet Zerona Z6
405nm violet laser light therapy.
Erchonia Violet Zerona Z6: 405nm violet diode low level laser device
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Erchonia Violet Zerona Z6
n=25 Participants
405nm violet laser light therapy.
Erchonia Violet Zerona Z6: 405nm violet diode low level laser device
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 2 weeksMean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.
Outcome measures
| Measure |
Erchonia Violet Zerona Z6
n=25 Participants
405nm violet laser light therapy.
Erchonia Violet Zerona Z6: 405nm violet diode low level laser device
|
|---|---|
|
Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs
|
-3.91 inches
Standard Deviation 1.649
|
Adverse Events
Erchonia Violet Zerona Z6
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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