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

Primary Purpose

Alopecia Areata, Alopecia, Balding

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hair transplantation
Hypodermic needle irritation
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia, Hair transplantation, Needle irritation, Medical needling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

alopecia areata

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 28, 2011
Last Updated
December 20, 2016
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT01385839
Brief Title
Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata
Official Title
Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata, Alopecia, Balding
Keywords
Alopecia, Hair transplantation, Needle irritation, Medical needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
alopecia areata
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Hair transplantation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hypodermic needle irritation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in follicular growth
Description
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Time Frame
day 0
Title
Change in follicular growth
Description
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Time Frame
day 1
Title
Change in follicular growth
Description
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Time Frame
2 weeks
Title
Change in follicular growth
Description
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Time Frame
24 weeks
Title
Change in follicular growth
Description
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Unger, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai, Department of Dermatology Clinical Trials Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20883369
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.
Results Reference
background
PubMed Identifier
16502201
Citation
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.
Results Reference
background
PubMed Identifier
18425901
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.
Results Reference
background
PubMed Identifier
19341938
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.
Results Reference
background
PubMed Identifier
19886963
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. Epub 2009 Nov 3. No abstract available.
Results Reference
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Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata

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