Treatment of Androgenetic Alopecia in Males and Females
Not Applicable
Completed
- Conditions
- Androgenetic Alopecia
- Registration Number
- NCT01437163
- Lead Sponsor
- Apira Science, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count After 16 weeks of therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Adolfo Fernandez-Obregon, MD
🇺🇸Hoboken, New Jersey, United States
Peter S. Halperin, MD
🇺🇸New York, New York, United States
Raymond J. Lanzafame, MD
🇺🇸Rochester, New York, United States
Jeffrey A. Sklar, MD
🇺🇸Woodbury, New York, United States
Adolfo Fernandez-Obregon, MD🇺🇸Hoboken, New Jersey, United States