Androgenetic Alopecia
Conditions
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.
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 first is donor strip harvest and stereomicroscopic dissection of the follicular unit grafts. The second is dissection and extraction of the follicular unit graft directly from the patient's scalp referred to as Follicular Unit Extraction or FUE. Potential benefits of the FUE technique may be less scalp scarring in the Donor Area, less patient discomfort and faster wound healing. Although the FUE approach to harvest has highly desirable attributes, it is technically difficult to perform, labor intensive, tedious and requires an excessive amount of time to harvest follicular units. These procedural factors have prevented the FUE approach from gaining wider adoption. Restoration Robotics, Inc. has developed the Restoration Robotics ARTAS™ Computer-Assisted Harvesting System to assist physicians in the harvest of hair follicles during hair transplantation procedures. The System mimics the manual FUE approach to harvesting follicular units and has the potential to solve the technical challenges inherent in the manual FUE technique. The ARTAS™ System is capable of identifying and harvesting hair follicles directly from the patient's scalp through a semi-automated process. The goal of the ARTAS™ System is to harvest the hair follicles while maintaining their critical anatomic structures intact.
Interventions
DEVICEARTAS™ System
Hair harvest using a computer-assisted system
PROCEDUREManual Hair Harvest
Hair harvesting via the manual technique
Sponsors
Restoration Robotics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
30 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in Hair Follicles Present | Change from Baseline at 9 Months | The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Harvested Follicles Transected | Time of harvest (Baseline) | The proportion of harvested hair follicles that were transected by each harvest method. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from June 19, 2009 to September 23, 2010 at hair restoration clinics.
Pre-assignment details
Once enrolled, subjects were scheduled for the treatment procedure. Subjects were randomized at the time of the treatment procedure.
Participants by arm
| Arm | Count |
|---|---|
| Computer-Assisted and Manual Harvest Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Computer-Assisted and Manual Harvest |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age Continuous | 48.6 years STANDARD_DEVIATION 7.5 |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
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.
Time frame: Change from Baseline at 9 Months
Population: The analysis was based on intention to treat (ITT). Imputation technique was based LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Harvest | Increase in Hair Follicles Present | 16.9 Hair follicles | Standard Deviation 18.3 |
| Computer-Assisted Harvest | Increase in Hair Follicles Present | 18.3 Hair follicles | Standard Deviation 18 |
Comparison: The hypothesis to be tested is one of non-inferiority. Tests of non-inferiority are one-sided tests and the significance level will be 0.025.p-value: 0.023t-test, 1 sided
Secondary
Proportion of Harvested Follicles Transected
The proportion of harvested hair follicles that were transected by each harvest method.
Time frame: Time of harvest (Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Harvest | Proportion of Harvested Follicles Transected | .264 Proportion of transected follicles | Standard Deviation 0.112 |
| Computer-Assisted Harvest | Proportion of Harvested Follicles Transected | .219 Proportion of transected follicles | Standard Deviation 0.146 |
Comparison: Paired data with each subject as their own control (treatment was randomly assigned to the left or right side of the scalp). Paired difference was analyzed.p-value: <0.001t-test, 1 sided