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

NCT01385839 | Terminated DMC

• 1 other identifier: GCO 08-0533
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata; Alopecia; Balding

Keywords

Alopecia; Hair transplantation; Needle irritation; Medical needling

Outcome Measures

Primary Outcomes (5)

• Change in follicular growth

  The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.

  day 0

• Change in follicular growth

  The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.

  day 1

• Change in follicular growth

  The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.

  2 weeks

• Change in follicular growth

  The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.

  24 weeks

• Change in follicular growth

  The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.

  36 weeks

Study Arms (1)

alopecia areata

EXPERIMENTAL

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; Procedure: Hypodermic needle irritation

Interventions

Hair transplantation PROCEDURE

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.

alopecia areata

Hypodermic needle irritation PROCEDURE

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.

alopecia areata

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects with active, progressive, alopecia areata.
• Subjects who are actively experiencing significant spontaneous regrowth of terminal hair.
• Subjects with autoimmune deficiency.
• Subjects with a medical condition contraindicating use of anesthesia.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai, Department of Dermatology Clinical Trials Center

New York, New York, 10029, United States

Location

Related Publications (5)

• Civas E, Aksoy B, Aksoy HM, Eski M, Yucel K. Hair transplantation for therapy-resistant alopecia areata of the eyebrows: is it the right choice? J Dermatol. 2010 Sep;37(9):823-6. doi: 10.1111/j.1346-8138.2010.00872.x.

  PMID: 20883369 BACKGROUND

• Barankin B, Taher M, Wasel N. Successful hair transplant of eyebrow alopecia areata. J Cutan Med Surg. 2005 Aug;9(4):162-4. doi: 10.1007/s10227-005-0136-x.

  PMID: 16502201 BACKGROUND

• Delamere FM, Sladden MM, Dobbins HM, Leonardi-Bee J. Interventions for alopecia areata. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004413. doi: 10.1002/14651858.CD004413.pub2.

  PMID: 18425901 BACKGROUND

• Garg S, Messenger AG. Alopecia areata: evidence-based treatments. Semin Cutan Med Surg. 2009 Mar;28(1):15-8. doi: 10.1016/j.sder.2008.12.002.

  PMID: 19341938 BACKGROUND

• Lee JW, Yoo KH, Kim BJ, Kim MN. Photodynamic therapy with methyl 5-aminolevulinate acid combined with microneedle treatment in patients with extensive alopecia areata. Clin Exp Dermatol. 2010 Jul;35(5):548-9. doi: 10.1111/j.1365-2230.2009.03695.x. Epub 2009 Nov 3. No abstract available.

  PMID: 19886963 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata; Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Robin Unger, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 30, 2011
• Study Start: October 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

US (1)