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OpenTrials
Completed

NCT Number: NCT04338295

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

The investigators propose to study the efficacy of micro-needling via the SOL Nova Device in generating hair growth in patients with Alopecia Areta (AA) who are either non-responsive or only partially responsive to combination oral JAK inhibitor plus oral minoxidil therapy.

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Key information

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

This will be a trial evaluating the efficacy of micro-needling via tattoo device in stimulating scalp hair growth in patients with AA refractory to combination JAK inhibitor and oral minoxidil treatment. Ten healthy subjects who are at least eighteen years of age who have experienced no or partial scalp hair regrowth after ≥three months of JAK inhibitor plus oral minoxidil treatment will be enrolled. Subjects will undergo a treatment session once every thirty days for a total of six sessions over six months and will complete a total of eight visits over eight months. Procedures and visits are not standard of care but conducted for research. Each visit will last about an hour. Approximately 30 minutes will be spent on consenting and time for patient to ask questions during the first visit. The remaining 30 minutes will be allotted for the investigator to determine if the patient meets criteria for trial enrollment. During the remaining visits, 20 minutes will be allotted for photography, 15-20 minutes for the procedure and 10-15 minutes for post-procedure patient assessment. Remaining 10 minutes on visits 2 and 8 will be used for biopsy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosis of AA
  • SALT score ≥90%
  • No or minimal scalp hair regrowth after ≥three months of oral JAK inhibitor plus oral minoxidil treatment

Exclusion criteria

  • Known concomitant androgenetic or other form of alopecia (in addition to AA)
  • 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 (SOL Nova Device)

Device

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

Primary outcomes

  1. Target area hair count (TAHC)

    Time frame: 6 months

    Total number of hairs in the area that undergoes microneedling

Secondary outcomes

  1. Hair phase

    Time frame: 6 months

    Number of catagen, anagen hairs

  2. Vellus hairs

    Time frame: 6 months

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

  3. Terminal hairs

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2020
Registry last updated
Dec 9, 2022

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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