Alopecia AreataNCT01385839
Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata
A study testing Hair transplantation and Hypodermic needle irritation in people with Alopecia Areata and Alopecia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata, Alopecia, Balding
- What is being tested?
- Hair transplantation and Hypodermic needle irritation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must have recalcitrant, quiescent, alopecia areata, non-responsive to treatment, for at least 6 months.
- 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.
Who cannot join
- Subjects with active, progressive, alopecia areata.
- Subjects who are actively experiencing significant spontaneous regrowth of terminal hair.
- Subjects with autoimmune deficiency.
- Subjects with a medical condition contraindicating use of anesthesia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai, Department of Dermatology Clinical Trials Center
New York, New York, 10029
About 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.
Read the 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.
- Conditions
- Alopecia Areata, Alopecia, Balding
- Being tested
- Hair transplantation, Hypodermic needle irritation
- Keywords
- Alopecia, Hair transplantation, Needle irritation, Medical needling
- Medical subject headings
- Alopecia Areata, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair transplantationProcedure or surgery
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 irritationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Hair transplantation; Procedure: Hypodermic needle irritation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in follicular growth
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Measured: day 0
Change in follicular growth
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Measured: day 1
Change in follicular growth
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Measured: 2 weeks
Change in follicular growth
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Measured: 24 weeks
Change in follicular growth
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startOct 2009
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Unger, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385839
- Sponsor's protocol ID
- GCO 08-0533
- Status last verified
- Dec 2016
- First submitted
- 28 Jun 2011
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20883369Barankin 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.
PubMed 16502201Delamere FM, Sladden MM, Dobbins HM, Leonardi-Bee J. Interventions for alopecia areata. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD004413. doi: 10.1002/14651858.CD004413.pub2.
PubMed 18425901Garg 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.
PubMed 19341938Lee 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.
PubMed 19886963
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata
- ClinicalTrials.gov ID
- NCT01385839
- Acronym / sponsor ID
- GCO 08-0533
- Conditions
- Alopecia Areata, Alopecia, Balding
- Keywords
- Alopecia, Hair transplantation, Needle irritation, Medical needling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| alopecia areata | Experimental | Procedure: Hair transplantation, Procedure: Hypodermic needle irritationpts 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject must have recalcitrant, quiescent, alopecia areata, non-responsive to treatment, for at least 6 months.
- 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.
Key exclusion criteria (4 listed)
- Subjects with active, progressive, alopecia areata.
- Subjects who are actively experiencing significant spontaneous regrowth of terminal hair.
- Subjects with autoimmune deficiency.
- Subjects with a medical condition contraindicating use of anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | alopecia areata |
| 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. | Procedure or surgery | alopecia areata |
Primary outcome
Change in follicular growth
Time frame: day 0
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Change in follicular growth
Time frame: day 1
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Change in follicular growth
Time frame: 2 weeks
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Change in follicular growth
Time frame: 24 weeks
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Change in follicular growth
Time frame: 36 weeks
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Background: PubMed 20883369Civas 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.
- Background: PubMed 16502201Barankin 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.
- Background: PubMed 18425901Delamere FM, Sladden MM, Dobbins HM, Leonardi-Bee J. Interventions for alopecia areata. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD004413. doi: 10.1002/14651858.CD004413.pub2.
- Background: PubMed 19341938Garg 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.
- Background: PubMed 19886963Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Unger, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hair transplantation and Hypodermic needle irritation in people with Alopecia Areata and Alopecia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in follicular growth (time frame: day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01385839, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2016.