Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata

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Brief Title

Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata

Official Title

Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata

Brief Summary

      The purpose of this study is to look at the safety, as well as the efficacy of hair
      transplantation compared with irritation with hypodermic needles in the treatment of subjects
      with refractory alopecia areata.

      With this study, the investigators hope to demonstrate that trauma is just as effective as
      hair transplant in the treatment of recalcitrant alopecia areata of the scalp.
    

Detailed Description

      Alopecia areata is a recurrent, non-scarring type of hair loss that can affect any
      hair-bearing area. This disorder can present in many different manners. Though medically
      benign, alopecia areata can result in severe emotional and psychosocial stress in affected
      individuals. This disease can be treated by hair transplantation.

      Hair transplantation is a procedure in which donor hair follicles are harvested from a
      section of a patient's scalp, and transplanted in another bald recipient area, at which time
      it will take root and continue to grow. Hairs generally continue to grow indefinitely

      During this study, subjects with alopecia areata will have one area (or ½ of a large area)
      treated by hair transplant and another (or the other ½) treated by simple irritation with a
      large gauge sterile hypodermic needle.
    


Study Type

Interventional


Primary Outcome

Change in follicular growth


Condition

Alopecia Areata

Intervention

Hair transplantation

Study Arms / Comparison Groups

 alopecia areata
Description:  pts will have one area (or ½ of a large area) treated by hair transplant and another (or the other ½) treated by simple irritation with a large gauge sterile hypodermic needle

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

Procedure

Estimated Enrollment

4

Start Date

October 2009

Completion Date

May 2012

Primary Completion Date

May 2012

Eligibility Criteria

        Inclusion Criteria:

          1. Subject must have recalcitrant, quiescent, alopecia areata, non-responsive to
             treatment, for at least 6 months.

          2. Subject must have one patch of alopecia areata greater than 5 cm diameter, of two
             patches of alopecia areata, each greater than 2.5 cm diameter.

        Exclusion Criteria:

          1. Subjects with active, progressive, alopecia areata.

          2. Subjects who are actively experiencing significant spontaneous regrowth of terminal
             hair.

          3. Subjects with autoimmune deficiency.

          4. Subjects with a medical condition contraindicating use of anesthesia.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Robin Unger, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01385839

Organization ID

GCO 08-0533


Responsible Party

Sponsor

Study Sponsor

Icahn School of Medicine at Mount Sinai


Study Sponsor

Robin Unger, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai


Verification Date

December 2016