NCT01017510

Brief 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. 1.Subcutaneous injection syringe Lower
  2. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 20, 2010

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

November 18, 2009

Last Update Submit

July 18, 2010

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

  • Evaluation of lesions will be based on Global assessment of improvement, score of 0-5

    1 year

Secondary Outcomes (1)

  • Pain level will be evaluated based on a scale of 0-10

    1 year

Interventions

Subcutaneous injection luer syringeDEVICE

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)DEVICE

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects over the age of 18
  • Men and women
  • The presence of at least two lesions (centers) in diameter of at least 1.5 cm on both sides of the scalp.
  • Healthy with no diseases that constitute the background against the total label use steroids

You may not qualify if:

  • Pregnant women
  • Involvement of more then 50% of the scalp
  • Patients with immunodeficiency-related diseases
  • Patients receiving systemic steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Rmat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • BOAZ AMI-CHI, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 20, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

July 20, 2010

Record last verified: 2010-07

Locations

IL(1)