Trial Outcomes & Findings for Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling (NCT NCT04342091)

NCT ID: NCT04342091

Last Updated: 2023-04-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2023-04-13

Participant Flow

Participant milestones

Measure	Microneedling Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

4 participants with frontal area analyzed (area of involvement)

Baseline characteristics by cohort

Measure	Microneedling n=6 Participants Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Age, Continuous	58.8 years STANDARD_DEVIATION 10.5 • n=6 Participants
Sex: Female, Male Female	6 Participants n=6 Participants
Sex: Female, Male Male	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	1 Participants n=6 Participants
Race (NIH/OMB) White	5 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Total area hair count (frontal)	50.0 Count per cm^2 STANDARD_DEVIATION 66.3 • n=4 Participants • 4 participants with frontal area analyzed (area of involvement)
Total hair count (vertex)	32.5 Count per cm^2 STANDARD_DEVIATION 6.4 • n=2 Participants • 2 participants with vertex area analyzed (area of involvement)
Hair shaft diameter (frontal)	62.3 micrometer STANDARD_DEVIATION 16.5 • n=4 Participants • 4 participants with frontal area analyzed (area of involvement)
Hair shaft diameter (vertex)	72.2 micrometer STANDARD_DEVIATION 7.1 • n=2 Participants • 2 participants with vertex area analyzed (area of involvement)
Number of hair follicles (frontal)	46.0 follicle count per cm^2 STANDARD_DEVIATION 55.8 • n=4 Participants • 4 participants with frontal area analyzed (area of involvement)
Number of hair follicles (vertex)	31.5 follicle count per cm^2 STANDARD_DEVIATION 2.1 • n=2 Participants • 2 participants with vertex area analyzed (area of involvement)
Vellus hairs (frontal)	0.8 Count per cm^2 STANDARD_DEVIATION 1.5 • n=4 Participants • 4 participants with frontal area analyzed (area of involvement)
Vellus hairs (vertex)	0 Count per cm^2 STANDARD_DEVIATION 0 • n=2 Participants • 2 participants with vertex area analyzed (area of involvement)
Terminal hairs (frontal)	49.3 Count per cm^2 STANDARD_DEVIATION 66.8 • n=4 Participants • 4 participants with frontal area analyzed (area of involvement)
Terminal hairs (vertex)	32.5 Count per cm^2 STANDARD_DEVIATION 6.4 • n=2 Participants • 2 participants with vertex area analyzed (area of involvement)

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Microneedling n=4 Participants Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Total Area Hair Count (Frontal)	86.8 Count per cm^2 Standard Deviation 73.0

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Microneedling n=2 Participants Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Total Area Hair Count (Vertex)	117.5 Count per cm^2 Standard Deviation 115.3

SECONDARY outcome

Timeframe: 6 months

Hair shaft diameter measured per trichoscopy

Outcome measures

Measure	Microneedling n=4 Participants Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Hair Shaft Diameters (Frontal)	61.1 micrometer Standard Deviation 19.6

SECONDARY outcome

Timeframe: 6 months

Hair shaft diameter measured per trichoscopy

Outcome measures

Measure	Microneedling n=2 Participants Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Hair Shaft Diameters (Vertex)	63.5 micrometer Standard Deviation 5.2

SECONDARY outcome

Timeframe: 6 months

Number of hair follicles counted per 1cm^2

Outcome measures

Measure	Microneedling n=4 Participants Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Number of Hair Follicles (Frontal)	70.3 Count per cm^2 Standard Deviation 59.6

SECONDARY outcome

Timeframe: 6 months

Number of hair follicles per 1 cm^2

Outcome measures

Measure	Microneedling n=2 Participants Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Number of Hair Follicles (Vertex)	74.0 Count per cm^2 Standard Deviation 53.7

SECONDARY outcome

Timeframe: 6 months

Number of vellus hairs per cm^2

Outcome measures

Measure	Microneedling n=4 Participants Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Vellus Hairs (Frontal)	1.5 Count per cm^2 Standard Deviation 3.0

SECONDARY outcome

Timeframe: 6 months

Number of vellus hairs per cm^2

Outcome measures

Measure	Microneedling n=2 Participants Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Vellus Hairs (Vertex)	0 Count per cm^2 Standard Deviation 0

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Microneedling n=4 Participants Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Terminal Hairs (Frontal)	85.3 Count per cm^2 Standard Deviation 74.6

SECONDARY outcome

Timeframe: 6 months

Number of terminal hairs per area of 1 cm^2

Outcome measures

Measure	Microneedling n=2 Participants Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Terminal Hairs (Vertex)	117.5 Count per cm^2 Standard Deviation 115.3

Adverse Events

Microneedling

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Microneedling n=6 participants at risk Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Gastrointestinal disorders Tongue Lesion (R Lateral Tongue)	16.7% 1/6 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders Hair shedding	16.7% 1/6 • 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