NCT02914587

Brief Summary

To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair follicle implantation method following a nine month period of post-procedure evaluation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

September 19, 2016

Last Update Submit

February 9, 2017

Conditions

Androgenic Alopecia

Outcome Measures

Primary Outcomes (1)

  • Hair Survival rate 9-months post procedure

    Hair survival rate

    9 month

Study Arms (2)

ARTAS System

EXPERIMENTAL

Implantation with the ARTAS System.

Device: ARTAS System

Manual Implantation

ACTIVE COMPARATOR

Implantation manually.

Other: Manual Implantation

Interventions

ARTAS SystemDEVICE
ARTAS System
Manual ImplantationOTHER
Manual Implantation

Eligibility Criteria

Age29 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of IV-VI;
  • Subject is 29 to 70 years old;
  • Subject has black or brown hair color;
  • Subject has straight hair;
  • Subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation;
  • Subject agrees to have 6 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 prior history of scalp reduction surgery(s);
  • Subject has prior history of hair restoration procedure(s) using the strip excision technique;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berman Skin Institute

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

September 19, 2016

First Posted

September 26, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations

US(1)