Trial Outcomes & Findings for Study of the Effect of Low Level Laser Light on Hair Growth on the Female Human Scalp (NCT NCT01292746)

Last Updated: 2015-12-11

Results Overview

Non-vellus terminal hair count was calculated across a tattooed 3 cm diameter scalp area from digital photographs of the area by independent blinded evaluator employing macroimage analysis software.

Recruitment status

TERMINATED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

Baseline and 13 Weeks

Results posted on

2015-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia MLS Erchonia MLS employs four diodes emitting 10 milliwatts (mW) 635 nanometer (nm) red laser light.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Effect of Low Level Laser Light on Hair Growth on the Female Human Scalp

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia MLS n=14 Participants The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	0 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	14 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	14 participants n=5 Participants
Non-Vellus Terminal Hair Count	171.57 hairs/cm2 STANDARD_DEVIATION 60.78 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 13 Weeks

Non-vellus terminal hair count was calculated across a tattooed 3 cm diameter scalp area from digital photographs of the area by independent blinded evaluator employing macroimage analysis software.

Outcome measures

Outcome measures
Measure	Erchonia MLS n=14 Participants Erchonia MLS: The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area	10.93 hairs/cm2 Standard Deviation 13.90

Adverse Events

Erchonia MLS

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place