Trial Outcomes & Findings for A Retrospective Analysis of the Effects of Low Level Laser Therapy on Toenail Onychomycosis (NCT NCT02588599)

Results Overview

Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 6 months post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

6 Months

Results posted on

2016-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia LUNULA The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
Overall Study STARTED	54
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Retrospective Analysis of the Effects of Low Level Laser Therapy on Toenail Onychomycosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia LUNULA n=54 Participants The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Each participant had only one great toenail treated in this study.

Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 6 months post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.

Outcome measures

Outcome measures
Measure	Erchonia LUNULA n=54 toenails The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
Percent (%) of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth	67 Percent of Toenails

SECONDARY outcome

Timeframe: Baseline and 6 Months

Population: Each participant in this study had only one great toenail treated.

Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 6 months after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.

Outcome measures

Outcome measures
Measure	Erchonia LUNULA n=54 toenails The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
Change in Millimeters (mm) of Clear Nail Bed	5.18 millimeters Standard Deviation 4.76

Adverse Events

Erchonia LUNULA

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

Kerry Zang DPM

Arizona Institute of Footcare Physicians

Phone: 480-834-8804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place