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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01017510
First received: November 18, 2009
Last updated: July 18, 2010
Last verified: July 2010
History of Changes

November 18, 2009
July 18, 2010
November 2009
November 2010   (final data collection date for primary outcome measure)
Evaluation of lesions will be based on Global assessment of improvement, score of 0-5 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01017510 on ClinicalTrials.gov Archive Site
Pain level will be evaluated based on a scale of 0-10 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparative Study Examining the Effectiveness in Use of a DERMOJET and a Normal Syringe Treatment for Patients With Hair Loss - Alopecia Areata
Comparative Study Examining the Effectiveness in Use of a DERMOJET and a Normal Syringe Treatment for Patients With Hair Loss - Alopecia Areata

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.
Not Provided
Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: Open Label
Alopecia Areata
  • Device: 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.

  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
Israel
 
NCT01017510
SHEBA-09-7322-BA-CTIL
No
Dr. Boaz Ami-Chi, Dermatology Dept Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: BOAZ AMI-CHI, MD Sheba Medical Center
Sheba Medical Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP