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

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Brief Title

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

Official Title

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

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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

Target area hair count (TAHC)

Secondary Outcome

 Hair phase

Condition

Alopecia Areata

Intervention

Tattoo machine (SOL Nova Device)

Study Arms / Comparison Groups

 Microneedling
Description:  Participants with Alopecia Areata will receive microneedling with a tattoo machine.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

July 15, 2020

Completion Date

August 1, 2021

Primary Completion Date

February 1, 2021

Eligibility Criteria

        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
      

Gender

Male

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, (203) 785-3482, [email protected]



Administrative Informations


NCT ID

NCT04338295

Organization ID

2000027352


Responsible Party

Sponsor

Study Sponsor

Yale University


Study Sponsor

, , 


Verification Date

June 2020