Status:
COMPLETED
Computer-Assisted Versus Manual Hair Harvest Comparative Study
Lead Sponsor:
Restoration Robotics, Inc.
Conditions:
Androgenetic Alopecia
Eligibility:
MALE
30-59 years
Phase:
NA
Brief Summary
The objective of this clinical study is to investigate and compare the safety and efficacy of the Restoration Robotics Computer-Assisted Harvesting System to the manual hair follicle harvesting method...
Detailed Description
A major technical step in hair transplantation is harvesting of the hair follicles. There are two accepted techniques for obtaining the hair grafts that are transplanted during the procedure. The firs...
Eligibility Criteria
Inclusion
- Subject is male with clinical diagnosis of androgenic alopecia with Norwood-Hamilton grade of IV-VII
- Subject is 30 to 59 years old
- Subject has black or brown hair color
- Subject has straight hair
- Subject agrees to cut hair short (\< 1 mm) on the scalp in the designated study areas for harvesting and implantation
- Subject agrees to have two dot tattoos placed on scalp
- Subject is able to understand and provide written consent; and
- Subject consents to post-operative follow-up per protocol.
Exclusion
- Subject has preponderance of grey/white hair
- Subject has blonde hair
- Subject has red hair
- Subject uses hair dye
- Subject has prior history of hair restoration procedure(s) using the strip excision technique
- Subject has prior history of scalp reduction surgery(s)
- Subject has helical hair (curly hair)
- Subject has wavy hair
- Subject has bleeding diathesis
- Subject has active use of anti-coagulation medication
- Subject has used finasteride in the previous 6 months, or plans to use finasteride during the study
- Subject has used minoxidil in the previous 2 weeks, or plans to use minoxidil during the study; or
- Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00926211
Start Date
June 1 2009
End Date
September 1 2010
Last Update
January 5 2012
Active Locations (2)
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1
Berman Skin Institute
Palo Alto, California, United States, 94304
2
A Practice of Hair Restoration
Walnut Creek, California, United States, 94596