Computer-Assisted Versus Manual Hair Harvest Comparative Study

Completed · Not applicable

Conditions studied: Androgenetic Alopecia

In brief

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 following a nine-month period of post-procedural evaluation.

Key facts

Study ID

NCT00926211

Run by

Restoration Robotics, Inc.

People needed

37

Starts

2009-06-01

Expected to finish

2010-09-01

Last updated by the study team

2012-01-05

Who can join

Age: 30 and older, up to 59. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Berman Skin Institute — Palo Alto, California, United States
• A Practice of Hair Restoration — Walnut Creek, California, United States

Full record on ClinicalTrials.gov

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