N/A
N=36
Computer-Assisted Versus Manual Hair Harvest Comparative Study
Androgenetic Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT00926211 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Increase in Hair Follicles Present — 16.9; 18.3 Hair follicles — p=0.023
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ARTAS™ System (Device); Manual Hair Harvest (Procedure)
- Age
- Adult · 30+ yrs
- Sex
- Male
- Sponsor
- Restoration Robotics, Inc.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Increase in Hair Follicles Present |
16.9; 18.3 | 0.023 sig |
| SECONDARY Proportion of Harvested Follicles Transected |
.264; .219 | <0.001 sig |
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 following a nine-month period of post-procedural evaluation.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00926211). 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.