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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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01017510
First Posted: November 20, 2009
Last Update Posted: July 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  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: None (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 ]

Secondary Outcome Measures:
  • Pain level will be evaluated based on a scale of 0-10 [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 18, 2009
First Posted: November 20, 2009
Last Update Posted: July 20, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents