Trial Outcomes & Findings for Study of the Use of Low Level Laser Light Therapy to Treat Toenail Fungus (NCT NCT01534689)

NCT ID: NCT01534689

Last Updated: 2015-12-11

Results Overview

Millimeter (mm) of clear nail from the base of the lunula was measured 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 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success. Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 105 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2015-12-11

Participant Flow

Participant milestones

Measure	Erchonia FX-405™ Laser The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
Overall Study STARTED	105
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Use of Low Level Laser Light Therapy to Treat Toenail Fungus

Baseline characteristics by cohort

Measure	Erchonia FX-405™ Laser n=105 Participants The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW Erchonia FX-405™ Laser: The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
Age, Continuous	59.5 years STANDARD_DEVIATION 12.85 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	41 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	3 Participants n=5 Participants
Race (NIH/OMB) White	102 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 United States	105 participants n=5 Participants
Percent (%) Toenail Onychomycosis Disease Involvement	57.39 percent of toenail STANDARD_DEVIATION 21.86 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Millimeter (mm) of clear nail from the base of the lunula was measured 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 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success.

Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria.

Outcome measures

Measure

Erchonia FX-405™ Laser n=105 Participants The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.

Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail

65 percentage of toenails

SECONDARY outcome

Timeframe: 12 weeks

Millimeter (mm) of clear nail from the base of the toenail lunula 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 3 months post-procedure administration. An increase in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has worsened and is negative for study success.

Outcome measures

Measure

Erchonia FX-405™ Laser n=105 Participants The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.

Change in Millimeter (mm) of Clear Nail Bed

4.99 millilmeters Standard Deviation 2.24

SECONDARY outcome

Timeframe: 12 weeks

Millimeter (mm) of clear nail from the base of the lunula was measured 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 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there.

Outcome measures

Measure

Erchonia FX-405™ Laser n=105 Participants The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.

Change in Percent (%) of mm Clear Nail

30.36 percentage of change in mm clear nail Standard Deviation 19.43

Adverse Events

Erchonia FX-405™ Laser

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: 6157129743

Email: elvira@reginsight.com

Results disclosure agreements

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