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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alopecia areata | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hair transplantation | Procedure | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Unger, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai, Department of Dermatology Clinical Trials Center | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20883369 | Background | 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. | |
| 16502201 | Background | 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. |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Hypodermic needle irritation | Procedure | 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. |
|
| 18425901 | Background | 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. |
| 19341938 | Background | 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. |
| 19886963 | Background | 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |