Clinical trial NCT01385839: Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata
Official title: Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alopecia Areata
Alopecia
Balding
Keywords: Alopecia
Hair transplantation
Needle irritation
Medical needling
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in follicular growth
timeFrame: day 0
measure: Change in follicular growth
timeFrame: day 1
measure: Change in follicular growth
timeFrame: 2 weeks
measure: Change in follicular growth
timeFrame: 24 weeks
measure: Change in follicular growth
timeFrame: 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai, Department of Dermatology Clinical Trials Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Robin Unger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.