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

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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.

Primary Measures

• Evaluation of lesions will be based on Global assessment of improvement, score of 0-5
  • Time Frame: 1 year
    Safety Issue?: No

Secondary Measures

• Pain level will be evaluated based on a scale of 0-10
  • Time Frame: 1 year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sheba Medical Center Other

Overall Clinical Trial Officials and Contacts

BOAZ AMI-CHI, MD Principal Investigator Sheba Medical Center  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01017510

Study ID Number: SHEBA-09-7322-BA-CTIL

ClinicalTrials.gov Identifier: NCT01017510

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration