Alopecia AreataNCT01017510
Comparative Study Examining the Effectiveness in Use of a DERMOJET and a Normal Syringe Treatment for Patients With Hair Loss - Alopecia Areata
A study testing Subcutaneous injection luer syringe and DERMOJET (a syringe without a needle) in people with Alopecia Areata, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Conventional treatments include the use of steroids applied locally, or injection in to the legion, or oral therapy. Treatment is determined by the severity of the disease. Injection in to the legion can be done in two methods 1. Subcutaneous injection syringe Lower 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Subcutaneous injection luer syringe and DERMOJET (a syringe without a needle)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to Nov 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects over the age of 18
- Men and women
- The presence of at least two lesions (centers) in diameter of at least 1.5 cm on both sides of the scalp.
- Healthy with no diseases that constitute the background against the total label use steroids
Who cannot join
- Pregnant women
- Involvement of more then 50% of the scalp
- Patients with immunodeficiency-related diseases
- Patients receiving systemic steroids
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Rmat Gan
Anna Lyakhovitsky, MD, 972-3-5302334
Anna Lyakhovitsky, MD
About this study
Conventional treatments include the use of steroids applied locally, or injection in to the legion, or oral therapy.
Treatment is determined by the severity of the disease.
Injection in to the legion can be done in two methods
- Subcutaneous injection syringe Lower
- Using syringe DERMOJET - a syringe without a needle. So far there are no publications in the medical literature of studies comparing efficacy, safety, convenience of use for doctor-patient, of both methods.
- Conditions
- Alopecia Areata
- Being tested
- Subcutaneous injection luer syringe, DERMOJET (a syringe without a needle)
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous injection luer syringeDevice
Right scalp: Luer syringe.
Left scalp: syringe without a needle.
All injections will contain 0.1 ml of Depo Medrol - Methylprednisolone acetate 40 mg/2 ml.
The distance between injection locations will be 1 cm.
DERMOJET (a syringe without a needle)Device
Right scalp: Luer syringe.
Left scalp: syringe without a needle.
All injections will contain 0.1 ml of Depo Medrol - Methylprednisolone acetate 40 mg/2 ml.
The distance between injection locations will be 1 cm.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of lesions will be based on Global assessment of improvement, score of 0-5
Measured: 1 year
Secondary outcomes (1)
Pain level will be evaluated based on a scale of 0-10
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- BOAZ AMI-CHI, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017510
- Sponsor's protocol ID
- SHEBA-09-7322-BA-CTIL
- Status last verified
- Jul 2010
- First submitted
- 18 Nov 2009
- Last updated
- 20 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Examining the Effectiveness in Use of a DERMOJET and a Normal Syringe Treatment for Patients With Hair Loss - Alopecia Areata
- ClinicalTrials.gov ID
- NCT01017510
- Acronym / sponsor ID
- SHEBA-09-7322-BA-CTIL
- Conditions
- Alopecia Areata
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 20 Nov 2009 (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.
Conventional treatments include the use of steroids applied locally, or injection in to the legion, or oral therapy.
Treatment is determined by the severity of the disease.
Injection in to the legion can be done in two methods
- Subcutaneous injection syringe Lower
- Using syringe DERMOJET - a syringe without a needle. So far there are no publications in the medical literature of studies comparing efficacy, safety, convenience of use for doctor-patient, of both methods.
Study design
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects over the age of 18
- Men and women
- The presence of at least two lesions (centers) in diameter of at least 1.5 cm on both sides of the scalp.
- Healthy with no diseases that constitute the background against the total label use steroids
Key exclusion criteria (4 listed)
- Pregnant women
- Involvement of more then 50% of the scalp
- Patients with immunodeficiency-related diseases
- Patients receiving systemic steroids
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 |
|---|---|---|
| Subcutaneous injection luer syringeRight scalp: Luer syringe. Left scalp: syringe without a needle. All injections will contain 0.1 ml of Depo Medrol - Methylprednisolone acetate 40 mg/2 ml. The distance between injection locations will be 1 cm. | Device | – |
| DERMOJET (a syringe without a needle)Right scalp: Luer syringe. Left scalp: syringe without a needle. All injections will contain 0.1 ml of Depo Medrol - Methylprednisolone acetate 40 mg/2 ml. The distance between injection locations will be 1 cm. | Device | – |
Primary outcome
Evaluation of lesions will be based on Global assessment of improvement, score of 0-5
Time frame: 1 year
1 secondary outcome
Pain level will be evaluated based on a scale of 0-10
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
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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.
BOAZ AMI-CHI, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous injection luer syringe and DERMOJET (a syringe without a needle) in people with Alopecia Areata, run by Sheba Medical Center at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Jul 2010. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of lesions will be based on Global assessment of improvement, score of 0-5 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2010.