NCT04341363

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

Completed NA Results posted Last updated 18 June 2023

What this trial tests

NA trial testing Tattoo machine in Androgenic Alopecia in 8 participants. Completed in 2 May 2022.

Timeline

9 April 2021

Primary endpoint
2 May 2022

2 May 2022

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	9 April 2021
Primary completion	2 May 2022
Estimated completion	2 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Tattoo machine

Conditions studied

• Androgenic Alopecia — all drugs for Androgenic Alopecia →

Sponsor

Yale University

Who can join

18 and older, male only, with Androgenic Alopecia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Area Hair Count Primary · 6 months

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

Group	Value	95% CI
Microneedling	126.8	± 41.7

SALT Score Secondary · 6 months

The Severity of Alopecia Tool measures percentage of scalp hair loss

Group	Value	95% CI
Microneedling	15.5	± 9.7

Hair Shaft Diameter Secondary · 6 months

The diameter of the hair shaft as measured by trichoscopy

Group	Value	95% CI
Microneedling	54.4	± 8.1

Number of Follicular Units Secondary · 6 months

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

Group	Value	95% CI
Microneedling	108.8	± 29.7

Vellus Hairs Secondary · 6 months

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

Group	Value	95% CI
Microneedling	18.0	± 26.3

Terminal Hairs Secondary · 6 months

Terminal hairs over an area of 1 cm\^2

Group	Value	95% CI
Microneedling	104.3	± 21.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Microneedling

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (1 terms — click to expand)

Reaction	System	Microneedling
Subdural hematoma	Vascular disorders	—

Data from ClinicalTrials.gov NCT04341363 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.