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OpenTrials
Completed

NCT Number: NCT04342091

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

To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia.

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06519, United States

About this study

The investigators propose an open label trial of tattoo machine microneedling in ten patients with fibrosing alopecia (five patients with CCCA and five with FFA). Ten healthy female 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). Photographs will be taken at each session. Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes. 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

  • Healthy Female
  • Diagnosing Fibrosing alopecia

Exclusion criteria

  • Any female with hair loss for other reasons
  • Males
  • Patients with cardiac conditions or renal insufficiency
  • Pregnant patients
  • Patients containing the following who would make poor candidates for microneedling, such as skin conditions, diabetes, 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

SOL Nova Device

Device

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

Primary outcomes

  1. Total Area Hair Count (Frontal)

    Time frame: 6 months

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

  2. Total Area Hair Count (Vertex)

    Time frame: 6 months

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

Secondary outcomes

  1. Hair Shaft Diameters (Frontal)

    Time frame: 6 months

    Hair shaft diameter measured per trichoscopy

  2. Hair Shaft Diameters (Vertex)

    Time frame: 6 months

    Hair shaft diameter measured per trichoscopy

  3. Number of Hair Follicles (Frontal)

    Time frame: 6 months

    Number of hair follicles counted per 1cm^2

  4. Number of Hair Follicles (Vertex)

    Time frame: 6 months

    Number of hair follicles per 1 cm^2

  5. Vellus Hairs (Frontal)

    Time frame: 6 months

    Number of vellus hairs per cm^2

  6. Vellus Hairs (Vertex)

    Time frame: 6 months

    Number of vellus hairs per cm^2

  7. Terminal Hairs (Frontal)

    Time frame: 6 months

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

  8. Terminal Hairs (Vertex)

    Time frame: 6 months

    Number of terminal hairs per area of 1 cm^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 10, 2020
Registry last updated
Apr 13, 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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