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

July 18, 2010 updated by: Sheba Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Rmat Gan, Israel
        • Recruiting
        • Sheba Medical Center
        • Contact:
          • Anna Lyakhovitsky, MD
          • Phone Number: 972-3-5302334
        • Sub-Investigator:
          • Anna Lyakhovitsky, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of lesions will be based on Global assessment of improvement, score of 0-5
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain level will be evaluated based on a scale of 0-10
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: BOAZ AMI-CHI, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

November 18, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (Estimate)

November 20, 2009

Study Record Updates

Last Update Posted (Estimate)

July 20, 2010

Last Update Submitted That Met QC Criteria

July 18, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-09-7322-BA-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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