Comparative Study Examining the Effectiveness in Use of a DERMOJET and a Normal Syringe Treatment for Patients With Hair Loss - Alopecia Areata

NCT ID: NCT01017510

Last Updated: 2010-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-11-30

Brief Summary

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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. 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.

Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Subcutaneous injection luer syringe

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects over the age of 18
2. Men and women
3. The presence of at least two lesions (centers) in diameter of at least 1.5 cm on both sides of the scalp.
4. Healthy with no diseases that constitute the background against the total label use steroids

Exclusion Criteria

1. Pregnant women
2. Involvement of more then 50% of the scalp
3. Patients with immunodeficiency-related diseases
4. Patients receiving systemic steroids
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dermatology Dept Sheba Medical Center

Principal Investigators

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BOAZ AMI-CHI, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Rmat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Anna Lyakhovitsky, MD

Role: primary

972-3-5302334

Other Identifiers

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SHEBA-09-7322-BA-CTIL

Identifier Type: -

Identifier Source: org_study_id

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