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

Alopecia Areata research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Alopecia Areata

Alopecia

Balding

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Hair transplantationHair 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.

Procedure:Hypodermic needle irritationIn 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

alopecia areatapts 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 Status

Terminated

Start Date: October 2009

Completed Date: May 2012

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change in follicular growth

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Robin Unger, MD

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01385839

Civaş 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.

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