Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata
NCT ID: NCT01385839
Last Updated: 2016-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2009-10-31
2012-05-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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alopecia areata
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
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.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.
Hypodermic needle irritation
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.
Interventions
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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.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.
Hypodermic needle irritation
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Principal Investigators
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Robin Unger, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai, Department of Dermatology Clinical Trials Center
New York, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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GCO 08-0533
Identifier Type: -
Identifier Source: org_study_id