N/A N=44 Randomized Quadruple-blind Treatment

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

Androgenetic Alopecia

Bottom Line

View on ClinicalTrials.gov: NCT01967277 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2015

Primary outcome: Primary: Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. — 12.48; 63.67 percent change — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Handi-Dome Laser (Device); Incandescent red light source. (Device)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Capillus, LLC
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.	12.48; 63.67	<0.001 sig
PRIMARY Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.	216.9; 189.3; 235.3; 268.3; 18.5; 89.9	—

Summary

This study will acquire data on hair growth of the head that is the result of treatment with a non-heat generating, laser product. This data will come from counting of terminal hairs before treatment begins and after treatment is completed. The treatment regime is every other day for 16 weeks.

Eligibility Criteria

Inclusion Criteria

Diagnosis of Androgenetic Alopecia / Female Pattern Hair Loss Fitzpatrick skin phototypes of I - IV Ludwig-Savin Hair Loss scale I - II In overall good health as determined by the physician investigator Active hair loss within the last 12 months Willingness to refrain from using all other hair growth products or treatments -

Exclusion Criteria

Photosensitivity to the specific wavelength of light - 650 nanometers. Malignancy in the target treatment area Other forms of alopecia of the head Past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously affects the scalp.

In willingness to remove hair replacement products during the 16 weeks of therapy.

Using any medications deemed to inhibit hair growth as determined by the physician investigator.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01967277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.