Trial Outcomes & Findings for Study of Erchonia Low Level Laser Light Therapy to Treat Toenail Fungus (NCT NCT02242019)

NCT ID: NCT02242019

Last Updated: 2016-05-17

Results Overview

Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks 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: 109 participants
• Primary outcome timeframe: Baseline and 36 Weeks
• Results posted on: 2016-05-17

Participant Flow

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	109
Overall Study COMPLETED	109
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Erchonia Low Level Laser Light Therapy to Treat Toenail Fungus

Baseline characteristics by cohort

Measure	Erchonia LUNULA n=109 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, Continuous	43.89 years STANDARD_DEVIATION 10.74 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	109 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Ireland	109 participants n=5 Participants
Duration of toenail onychomycosis Involvement	25.99 months STANDARD_DEVIATION 18.43 • n=5 Participants
Percent Toenail Onychomycosis Disease Involvement	63.21 percentage of toenail STANDARD_DEVIATION 23.88 • n=5 Participants
Millimeter (mm) of Clear Nail From the Lunula	5.90 millimeters (mm) STANDARD_DEVIATION 4.58 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 36 Weeks

Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks 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

Measure	Erchonia LUNULA n=139 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.
Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth	134 toenails

PRIMARY outcome

Timeframe: Baseline and 36 Weeks

Population: Some subjects had multiple toenails with onychomycosis disease involvement that were treated and analyzed, resulting in a total of 139 study toenails being analyzed.

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 36 weeks 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

Measure	Erchonia LUNULA n=139 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	8.36 millimeters (mm) Standard Deviation 4.08

SECONDARY outcome

Timeframe: Baseline and 36 Weeks

The percent (%) of the toenail that had onychomycosis disease involvement was determined. Change in the % of toenail onychomycosis disease involvement was calculated as the difference in the % of toenail onychomycosis disease involvement from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. A decrease in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has decreased and is positive for study success. An increase in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has increased and is negative for study success.

Outcome measures

Measure	Erchonia LUNULA n=139 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 Percent (%) of Onychomycosis Disease Involvement	57.76 percentage of disease involvement Standard Deviation 21.97

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

Clinical Consultant

Regulatory Insight, Inc.

Phone: 615-712-9743

Email: elvira@reginsight.com

Results disclosure agreements

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