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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

June 28, 2011
December 20, 2016
October 2009
May 2012   (Final data collection date for primary outcome measure)
  • 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.
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.
Complete list of historical versions of study NCT01385839 on ClinicalTrials.gov Archive Site
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Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata
Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Alopecia Areata
  • Alopecia
  • Balding
  • 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.
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
Interventions:
  • Procedure: Hair transplantation
  • Procedure: Hypodermic needle irritation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
May 2012
May 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01385839
GCO 08-0533
Yes
Not Provided
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Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
Not Provided
Principal Investigator: Robin Unger, MD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP