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Completed

NCT Number: NCT04341363

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

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).

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Key information

Conditions

Androgenic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tattoo machine

Device

A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.

Primary outcomes

  1. Total Area Hair Count

    Time frame: 6 months

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

Secondary outcomes

  1. SALT Score

    Time frame: 6 months

    The Severity of Alopecia Tool measures percentage of scalp hair loss

  2. Hair Shaft Diameter

    Time frame: 6 months

    The diameter of the hair shaft as measured by trichoscopy

  3. Number of Follicular Units

    Time frame: 6 months

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

  4. Vellus Hairs

    Time frame: 6 months

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

  5. Terminal Hairs

    Time frame: 6 months

    Terminal hairs over an area of 1 cm^2

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 10, 2020
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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