Androgenetic Alopecia
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy system configured in a novel product called the TopHat 655 system, for promoting hair growth in males and females diagnosed with androgenetic alopecia of the head.
Interventions
DEVICETopHat 655 rejuvenation system
TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period
DEVICELaser and/or Light Hair Rejuvenation System
A red incandescent light source replaces all lasers and light emitting diodes.
Sponsors
Apira Science, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of androgenetic alopecia * Fitzpatrick Skin Phototypes I-IV * Norwood-Hamilton IIa to V for males and Ludwig I or II for females * Active hair loss within the last 12 months * Willingness to refrain from using all other hair growth products or treatments * In overall general good health as determined by the physician investigator
Exclusion criteria
* Photosensitivity to laser light and non-laser LED light operating at 655nms. * 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 effects the scalp * Unwillingness to remove hair replacement products during the therapy sessions * Using any medications deemed to inhibit hair growth as determined by the physician investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count | After 16 weeks of therapy |
Countries
United States
Outcome results
None listed