A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy

• ClinicalTrials.gov Identifier: NCT01967277
• Recruitment Status: Completed
• First Posted: October 22, 2013
• Results First Posted: May 6, 2015
• Last Update Posted: May 6, 2015
• Sponsor: Capillus, LLC
• Information provided by (Responsible Party): Capillus, LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Androgenetic Alopecia
• Interventions: Device: Handi-Dome Laser; Device: Incandescent red light source.
• Enrollment: 44

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Incandescent Red Light Source	Handi-Dome Laser
Arm/Group Description	Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks. Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.	Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks. Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.
Period Title: Overall Study
Started	22	22
Completed	21	19
Not Completed	1	3
Reason Not Completed
Lost to Follow-up	1	2
Unrelated illness	0	1

Baseline Characteristics

Arm/Group Title		Incandescent Red Light Source	Handi-Dome Laser	Total
Arm/Group Description		Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks. Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.	Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks. Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		22	22	44
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	22 participants	22 participants	44 participants
		49; (28 to 60)	49.5; (28 to 58)	49; (28 to 60)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	22 participants	44 participants
	Female	22 100.0%	22 100.0%	44 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	22 participants	22 participants	44 participants
		22	22	44

Outcome Measures

1. Primary Outcome

Title	Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Description	At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Time Frame	baseline and 17 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Incandescent Red Light Source	Handi-Dome Laser
Arm/Group Description:	Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks. Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.	Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks. Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.
Overall Number of Participants Analyzed	21	19
Mean (Standard Deviation); Unit of Measure: percent change
	12.48 (13.76)	63.67 (50.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Incandescent Red Light Source, Handi-Dome Laser
	Comments	H0: µL ≤ µs Versus Ha: µL > µs
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

2. Primary Outcome

Title	Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Description	At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Time Frame	baseline and 17 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Incandescent Red Light Source	Handi-Dome Laser
Arm/Group Description:	Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks. Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.	Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks. Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.
Overall Number of Participants Analyzed	21	19
Mean (Standard Deviation); Unit of Measure: terminal hairs
Hair count, baseline	216.9 (109.1)	189.3 (85.8)
Hair count, post treatment	235.3 (105.8)	268.3 (117.7)
Hair count, difference	18.5 (24.4)	89.9 (63.3)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Incandescent Red Light Source	Handi-Dome Laser
Arm/Group Description	Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks. Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.	Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks. Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.
All-Cause Mortality
	Incandescent Red Light Source	Handi-Dome Laser
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Incandescent Red Light Source	Handi-Dome Laser
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/22 (0.00%)	0/22 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Incandescent Red Light Source	Handi-Dome Laser
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/22 (0.00%)	0/22 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

PI may not disclose the results of the trial.

Results Point of Contact

• Name/Title: Patricia Schnoor
• Organization: Capillus LLC
• Phone: 7868881874
• EMail: pschnoor@capillus.com

• Responsible Party: Capillus, LLC
• ClinicalTrials.gov Identifier: NCT01967277
• Other Study ID Numbers: USC650
• First Submitted: October 18, 2013
• First Posted: October 22, 2013
• Results First Submitted: May 5, 2015
• Results First Posted: May 6, 2015
• Last Update Posted: May 6, 2015