Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Alopecia Areata Alopecia Balding |
Procedure: Hair transplantation Procedure: Hypodermic needle irritation |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata |
- Change in follicular growth [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2009 |
-
Procedure: Hair transplantation
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Jason J Emer, MD | 212-241-3288 ext 43288 | jason.emer@mssm.edu |
| Contact: Giselle J Singer | 212-241-3288 ext 43288 | giselle.singer@mssm.edu |
| United States, New York | |
| Mount Sinai School of Medicine, Department of Dermatology Clinical Trials Center | Recruiting |
| New York, New York, United States, 10029 | |
| Principal Investigator: Jason J Emer, MD | |
| Sub-Investigator: Robin Unger, MD | |
More Information
Additional Information:
Publications:
| Responsible Party: | Jason Emer, M.D., Mount Sinai School of Medicine, Department of Dermatology |
| ClinicalTrials.gov Identifier: | NCT01385839 History of Changes |
| Other Study ID Numbers: | 08-0533 |
| Study First Received: | June 28, 2011 |
| Last Updated: | June 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emer, Jason, M.D.:
|
Alopecia Hair transplantation Needle irritation Medical needling |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013