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

Sponsor
Yale University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04342091
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
29.7
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: SOL Nova Device
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling
Actual Study Start Date :
Apr 9, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Microneedling

Participants with fibrosing alopecia will receive microneedling with a tattoo machine.

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

Outcome Measures

Primary Outcome Measures

  1. Total area hair count [6 months]

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

Secondary Outcome Measures

  1. Hair shaft diameters [6 months]

    Hair shaft diameter measured per trichoscopy

  2. Number of hair follicles [6 months]

    Number of hair follicles per 1cm^2

  3. Yellow dots [6 months]

    Presence and number of yellow dots on trichoscopy per 1cm^2

  4. White dots [6 months]

    Presence and number of white dots on tricoscopy per 1cm^2

  5. Perifollicular halo [6 months]

    Presence and number of perifollicular halo on trichoscopy per 1cm^2

  6. Vellus hairs [6 months]

    Ratio of vellus hairs to terminal hairs over an area of 1cm^2

  7. Terminal hairs [6 months]

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

  8. Hair phase [6 months]

    Number of catagen, anagen hairs

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale University New Haven Connecticut United States 06519

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Brett King, MD, PhD, Associate Professor of Dermatology, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT04342091
Other Study ID Numbers:
  • 2000027405
First Posted:
Apr 10, 2020
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Alopecia
Alopecia Areata

Study Results

No Results Posted as of Jul 12, 2022