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

Primary Purpose

Fibrosing Alopecia, Frontal Fibrosing Alopecia, Central Centrifugal Cicatricial Alopecia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SOL Nova Device
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrosing Alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microneedling

Arm Description

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

Outcomes

Primary Outcome Measures

Total Area Hair Count (Frontal)
Total number of hairs over an area of 1cm^2
Total Area Hair Count (Vertex)
Total number of hairs over an area of 1 cm^2

Secondary Outcome Measures

Hair Shaft Diameters (Frontal)
Hair shaft diameter measured per trichoscopy
Hair Shaft Diameters (Vertex)
Hair shaft diameter measured per trichoscopy
Number of Hair Follicles (Frontal)
Number of hair follicles counted per 1cm^2
Number of Hair Follicles (Vertex)
Number of hair follicles per 1 cm^2
Vellus Hairs (Frontal)
Number of vellus hairs per cm^2
Vellus Hairs (Vertex)
Number of vellus hairs per cm^2
Terminal Hairs (Frontal)
Number of terminal hairs over an area of 1 cm^2
Terminal Hairs (Vertex)
Number of terminal hairs per area of 1 cm^2

Full Information

First Posted
April 6, 2020
Last Updated
March 21, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT04342091
Brief Title
Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling
Official Title
Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
April 8, 2022 (Actual)
Study Completion Date
April 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosing Alopecia, Frontal Fibrosing Alopecia, Central Centrifugal Cicatricial Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microneedling
Arm Type
Experimental
Arm Description
Participants with fibrosing alopecia will receive microneedling with a tattoo machine.
Intervention Type
Device
Intervention Name(s)
SOL Nova Device
Intervention Description
A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Primary Outcome Measure Information:
Title
Total Area Hair Count (Frontal)
Description
Total number of hairs over an area of 1cm^2
Time Frame
6 months
Title
Total Area Hair Count (Vertex)
Description
Total number of hairs over an area of 1 cm^2
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hair Shaft Diameters (Frontal)
Description
Hair shaft diameter measured per trichoscopy
Time Frame
6 months
Title
Hair Shaft Diameters (Vertex)
Description
Hair shaft diameter measured per trichoscopy
Time Frame
6 months
Title
Number of Hair Follicles (Frontal)
Description
Number of hair follicles counted per 1cm^2
Time Frame
6 months
Title
Number of Hair Follicles (Vertex)
Description
Number of hair follicles per 1 cm^2
Time Frame
6 months
Title
Vellus Hairs (Frontal)
Description
Number of vellus hairs per cm^2
Time Frame
6 months
Title
Vellus Hairs (Vertex)
Description
Number of vellus hairs per cm^2
Time Frame
6 months
Title
Terminal Hairs (Frontal)
Description
Number of terminal hairs over an area of 1 cm^2
Time Frame
6 months
Title
Terminal Hairs (Vertex)
Description
Number of terminal hairs per area of 1 cm^2
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett King, MD, PhD
Organizational Affiliation
Associate Professor of Dermatology, Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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