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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Emer, Jason, M.D..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Emer, Jason, M.D.
ClinicalTrials.gov Identifier:
NCT01385839
First received: June 28, 2011
Last updated: June 29, 2011
Last verified: June 2011

June 28, 2011
June 29, 2011
October 2009
Not Provided
Change in follicular growth [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Same as current
Complete list of historical versions of study NCT01385839 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Not Provided
Not Provided

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.
Both
18 Years and older
Yes
Contact: Jason J Emer, MD 212-241-3288 ext 43288 jason.emer@mssm.edu
Contact: Giselle J Singer 212-241-3288 ext 43288 giselle.singer@mssm.edu
United States
 
NCT01385839
08-0533
Yes
Jason Emer, M.D., Mount Sinai School of Medicine, Department of Dermatology
Emer, Jason, M.D.
Not Provided
Not Provided
Emer, Jason, M.D.
June 2011

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