Computer-Assisted Versus Manual Hair Harvest Comparative Study

NCT00926211 | Completed Results

• 1 other identifier: RR-09-0002
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• Increase in Hair Follicles Present

  The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline.

  Change from Baseline at 9 Months

Secondary Outcomes (1)

• Proportion of Harvested Follicles Transected

  Time of harvest (Baseline)

Study Arms (2)

Computer-Assisted

EXPERIMENTAL

Hair harvest using the computer-assisted system

Device: ARTAS™ System

Manual Harvest

ACTIVE COMPARATOR

Hair harvesting via manual technique

Procedure: Manual Hair Harvest

Interventions

ARTAS™ System DEVICE

Hair harvest using a computer-assisted system

Computer-Assisted

Manual Hair Harvest PROCEDURE

Hair harvesting via the manual technique

Manual Harvest

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Restoration Robotics, Inc.: lead

Study Sites (2)

Berman Skin Institute

Palo Alto, California, 94304, United States

Location

A Practice of Hair Restoration

Walnut Creek, California, 94596, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Miguel Canales, M.D.
• Organization: Restoration Robotics

miguel@restorationrobotics.com

650-965-3612

Study Officials

• Miguel Canales, M.D.

  Restoration Robotics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 23, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 5, 2012
• Results First Posted: December 8, 2011

Record last verified: 2011-09

Locations

US (2)