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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alopecia Areata, Alopecia, Balding

Intervention / Treatment
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* Procedure: Hair transplantation
* Procedure: Hypodermic needle irritation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alopecia areata<br>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<br>* 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.<br>Procedure: Hypodermic needle irritation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alopecia, Hair transplantation, Needle irritation, Medical needling