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

Not Applicable

Terminated

• Conditions: Alopecia; Balding; Alopecia Areata
• Interventions: Procedure: Hair transplantation; Procedure: Hypodermic needle irritation

• Registration Number: NCT01385839
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
alopecia areata	Hypodermic needle irritation	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
alopecia areata	Hair transplantation	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai, Department of Dermatology Clinical Trials Center; 🇺🇸 New York, New York, United States