Androgenic Alopecia
Conditions
Brief summary
The intent of this study is to evaluate the efficacy of microneedling through use of a professional tattoo machine in hair regrowth in patients with androgenic alopecia (AGA) over up to 6 treatments (6 months).
Detailed description
Proposed is an open label trial of tattoo machine microneedling in ten patients with androgenic alopecia. Ten healthy male patients older than 18 years will undergo 6 microneedling sessions. Over the course of six months, subjects will undergo up to six treatment sessions (one session every 30 day). Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes.
Interventions
DEVICETattoo machine
A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Symmetric hair loss from AGA * Hamilton-Norwood IIIa, III, III vertex, IV, Iva, V with low density hair coverage over majority of alopecic areas * No or minimal scalp hair regrowth on oral and/or topical minoxidil
Exclusion criteria
* Any male with hair loss for other reasons * Unilateral or asymmetric hair loss * Hamilton-Norwood I, II, IIa, Va, IV, VII x * Patients without hair * Patients with the following who would make poor candidates for microneedling such as skin conditions, diabetes, or history of keloid formation * Anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Area Hair Count | 6 months | Total number of hairs in an area of 1 cm\^2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SALT Score | 6 months | The Severity of Alopecia Tool measures percentage of scalp hair loss |
| Hair Shaft Diameter | 6 months | The diameter of the hair shaft as measured by trichoscopy |
| Number of Follicular Units | 6 months | Number of follicular units with one or more hair follicles over an area of 1cm\^2 |
| Vellus Hairs | 6 months | Number of vellus hairs over an area of 1 cm\^2 |
| Terminal Hairs | 6 months | Terminal hairs over an area of 1 cm\^2 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Microneedling Participants with androgenic alopecia will receive microneedling with a tattoo machine.
Tattoo machine: A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Microneedling |
|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hair Shaft Diameters | 58.0 micrometer STANDARD_DEVIATION 15.8 |
| Number of hair follicles | 96.3 hair follicles per cm^2 STANDARD_DEVIATION 37.9 |
| Number of Terminal Hairs | 87.1 terminal hairs per cm^2 STANDARD_DEVIATION 33.2 |
| Number of Vellus Hairs | 13.3 vellus hairs per cm^2 STANDARD_DEVIATION 14.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 8 Participants |
| SALT Score | 25.0 percentage of hair loss STANDARD_DEVIATION 20.2 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 6 Participants |
| Total area hair count | 100.4 hairs per cm^2 STANDARD_DEVIATION 41.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Total Area Hair Count
Total number of hairs in an area of 1 cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Total Area Hair Count | 126.8 hairs per cm^2 | Standard Deviation 41.7 |
Secondary
Hair Shaft Diameter
The diameter of the hair shaft as measured by trichoscopy
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Hair Shaft Diameter | 54.4 micrometer | Standard Deviation 8.1 |
Secondary
Number of Follicular Units
Number of follicular units with one or more hair follicles over an area of 1cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Number of Follicular Units | 108.8 follicular units per cm^2 | Standard Deviation 29.7 |
Secondary
SALT Score
The Severity of Alopecia Tool measures percentage of scalp hair loss
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | SALT Score | 15.5 percentage of hair loss | Standard Deviation 9.7 |
Secondary
Terminal Hairs
Terminal hairs over an area of 1 cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Terminal Hairs | 104.3 terminal hairs per cm^2 | Standard Deviation 21.9 |
Secondary
Vellus Hairs
Number of vellus hairs over an area of 1 cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Vellus Hairs | 18.0 vellus hairs per cm^2 | Standard Deviation 26.3 |