Trial Outcomes & Findings for Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling (NCT NCT04341363)

NCT ID: NCT04341363

Last Updated: 2023-06-18

Results Overview

Total number of hairs in an area of 1 cm\^2

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2023-06-18

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling

Baseline characteristics by cohort

Measure	Microneedling n=8 Participants 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.
Age, Continuous	50.4 years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants
Total area hair count	100.4 hairs per cm^2 STANDARD_DEVIATION 41.4 • n=5 Participants
SALT Score	25.0 percentage of hair loss STANDARD_DEVIATION 20.2 • n=5 Participants
Hair Shaft Diameters	58.0 micrometer STANDARD_DEVIATION 15.8 • n=5 Participants
Number of hair follicles	96.3 hair follicles per cm^2 STANDARD_DEVIATION 37.9 • n=5 Participants
Number of Vellus Hairs	13.3 vellus hairs per cm^2 STANDARD_DEVIATION 14.7 • n=5 Participants
Number of Terminal Hairs	87.1 terminal hairs per cm^2 STANDARD_DEVIATION 33.2 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Total number of hairs in an area of 1 cm^2

Outcome measures

Measure	Microneedling n=6 Participants 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.
Total Area Hair Count	126.8 hairs per cm^2 Standard Deviation 41.7

SECONDARY outcome

Timeframe: 6 months

The Severity of Alopecia Tool measures percentage of scalp hair loss

Outcome measures

Measure	Microneedling n=6 Participants 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.
SALT Score	15.5 percentage of hair loss Standard Deviation 9.7

SECONDARY outcome

Timeframe: 6 months

The diameter of the hair shaft as measured by trichoscopy

Outcome measures

Measure	Microneedling n=6 Participants 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.
Hair Shaft Diameter	54.4 micrometer Standard Deviation 8.1

SECONDARY outcome

Timeframe: 6 months

Number of follicular units with one or more hair follicles over an area of 1cm^2

Outcome measures

Measure	Microneedling n=6 Participants 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.
Number of Follicular Units	108.8 follicular units per cm^2 Standard Deviation 29.7

SECONDARY outcome

Timeframe: 6 months

Number of vellus hairs over an area of 1 cm^2

Outcome measures

Measure	Microneedling n=6 Participants 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.
Vellus Hairs	18.0 vellus hairs per cm^2 Standard Deviation 26.3

SECONDARY outcome

Timeframe: 6 months

Terminal hairs over an area of 1 cm^2

Outcome measures

Measure	Microneedling n=6 Participants 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.
Terminal Hairs	104.3 terminal hairs per cm^2 Standard Deviation 21.9

Adverse Events

Microneedling

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Microneedling n=8 participants at risk 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.
Vascular disorders Subdural hematoma	12.5% 1/8 • Number of events 1 • 6 months

Additional Information

Brett King

Yale University

Phone: (203) 785-7421

Email: Brett.King@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place