Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata
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| First Received Date ICMJE | June 28, 2011 | ||||||||
| Last Updated Date | June 29, 2011 | ||||||||
| Start Date ICMJE | October 2009 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01385839 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata | ||||||||
| Official Title ICMJE | Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01385839 | ||||||||
| Other Study ID Numbers ICMJE | 08-0533 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Jason Emer, M.D., Mount Sinai School of Medicine, Department of Dermatology | ||||||||
| Study Sponsor ICMJE | Emer, Jason, M.D. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Emer, Jason, M.D. | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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