NCT04338295

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

April 9, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

April 3, 2020

Last Update Submit

December 7, 2022

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

  • Target area hair count (TAHC)

    Total number of hairs in the area that undergoes microneedling

    6 months

Secondary Outcomes (3)

  • Hair phase

    6 months

  • Vellus hairs

    6 months

  • Terminal hairs

    6 months

Study Arms (1)

Microneedling

EXPERIMENTAL

Participants with Alopecia Areata will receive microneedling with a tattoo machine.

Device: Tattoo machine (SOL Nova Device)

Interventions

Tattoo machine (SOL Nova Device)DEVICE

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

Microneedling

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Brett King, MD, PhD

    Associate Professor of Dermatology, Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 8, 2020

Study Start

April 9, 2021

Primary Completion

May 16, 2022

Study Completion

May 16, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)