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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01385839
• Other study ID #: GCO 08-0533
• Status: Terminated
• Phase: N/A
• First received: June 28, 2011
• Last updated: December 20, 2016
• Start date: October 2009
• Est. completion date: May 2012

Study information

• Verified date: December 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Balding

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai, Department of Dermatology Clinical Trials Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (5)

Barankin B, Taher M, Wasel N. Successful hair transplant of eyebrow alopecia areata. J Cutan Med Surg. 2005 Aug;9(4):162-4. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in follicular growth	The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.	day 0	No
Primary	Change in follicular growth	The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.	day 1	No
Primary	Change in follicular growth	The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.	2 weeks	No
Primary	Change in follicular growth	The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.	24 weeks	No
Primary	Change in follicular growth	The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.	36 weeks	No

External Links

•   National Alopecia Areata Foundation