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

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

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 weeks

Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.

Outcome measures

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

Clinical Affairs Manager

Erchonia Corporation

Phone: 8882420571

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place