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

This study has been terminated.
(low enrollment)
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01385839
First received: June 28, 2011
Last updated: December 20, 2016
Last verified: December 2016
  Purpose

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.


Condition Intervention
Alopecia Areata Alopecia Balding Procedure: Hair transplantation Procedure: Hypodermic needle irritation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Change in follicular growth [ Time Frame: day 0 ]
    The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.

  • Change in follicular growth [ Time Frame: day 1 ]
    The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.

  • Change in follicular growth [ Time Frame: 2 weeks ]
    The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.

  • Change in follicular growth [ Time Frame: 24 weeks ]
    The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.

  • Change in follicular growth [ Time Frame: 36 weeks ]
    The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.


Enrollment: 4
Study Start Date: October 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alopecia areata
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
Procedure: 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.Hair transplant involves mild sedation with Valium, followed by local anesthesia of the donor and recipient areas. Donor hair is harvested using a scalpel to cut narrow strips of hair bearing areas. Follicular units are obtained by slicing the donor tissue into naturally occurring groupings. The follicular units are placed into holes made by a hypodermic needle in the alopecia areata affected areas of the subject. Grafts are held in place by coagulated blood. A bandage is applied after the procedure and left in place over night. The following day, the patient returns for follow up, bandage removal, cleansing, hair washing, and a check up.
Procedure: Hypodermic needle irritation
In the areas which are simply treated with irritation with the hypodermic needle, the procedure is the same, except no follicular units are placed into the holes.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385839

Locations
United States, New York
Icahn School of Medicine at Mount Sinai, Department of Dermatology Clinical Trials Center
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Robin Unger, MD Icahn School of Medicine at Mount Sinai
  More Information

Additional Information:
Publications:
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01385839     History of Changes
Other Study ID Numbers: GCO 08-0533
Study First Received: June 28, 2011
Last Updated: December 20, 2016

Keywords provided by Icahn School of Medicine at Mount Sinai:
Alopecia
Hair transplantation
Needle irritation
Medical needling

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 24, 2017