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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01017510
• Other study ID #: SHEBA-09-7322-BA-CTIL
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2009
• Last updated: July 18, 2010
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: July 2010
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Rmat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of lesions will be based on Global assessment of improvement, score of 0-5		1 year	No
Secondary	Pain level will be evaluated based on a scale of 0-10		1 year	No