Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.

Condition Intervention
Alopecia Areata
Device: Subcutaneous injection luer syringe
Device: DERMOJET (a syringe without a needle)

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Comparative Study Examining the Effectiveness in Use of a DERMOJET and a Normal Syringe Treatment for Patients With Hair Loss - Alopecia Areata

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Evaluation of lesions will be based on Global assessment of improvement, score of 0-5 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain level will be evaluated based on a scale of 0-10 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017510

Locations
Israel
Sheba Medical Center Recruiting
Rmat Gan, Israel
Contact: Anna Lyakhovitsky, MD    972-3-5302334      
Sub-Investigator: Anna Lyakhovitsky, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: BOAZ AMI-CHI, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Boaz Ami-Chi, Dermatology Dept Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01017510     History of Changes
Other Study ID Numbers: SHEBA-09-7322-BA-CTIL
Study First Received: November 18, 2009
Last Updated: July 18, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hair Diseases
Hypotrichosis
Pathological Conditions, Anatomical
Skin Diseases
Methylprednisolone acetate
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014