Status:
TERMINATED
Intralesional Steroids in the Treatment of Alopecia Areata
Lead Sponsor:
Columbia University
Collaborating Sponsors:
University of Minnesota
Conditions:
Alopecia Areata
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study aims to determine the frequency of response to treatment with 3 concentrations of IL TAC, 2.5mg/ml, 5mg/ml or 10mg/ml as well as the duration of response and incidence of side effects compa...
Detailed Description
Alopecia areata (AA) is a major medical problem and is the most prevalent autoimmune disease in the US. AA represents the second most common form of hair loss and causes significant disfigurement and ...
Eligibility Criteria
Inclusion
- Patients 18 to 75 years of age
- Patients with a diagnosis of patch type alopecia areata
- Patients will have up to 50% total scalp hair loss at baseline as measured by the Severity of Alopecia Tool (SALT) score
- Duration of hair loss ranging from 3 to 12 months with no evidence of regrowth present at baseline in the areas to be injected
Exclusion
- Patients with a history of or existing skin diseases affecting the scalp such as psoriasis or seborrheic dermatitis and patients with evidence of infection or skin cancer in the treated areas
- Patients in whom the diagnosis of alopecia areata is questionable
- Patients in whom regrowth is present/evident at baseline in the areas to be treated
- Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma of the skin) which in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections
- Women of childbearing potential who are unable or unwilling to use two forms of birth control for the study duration or women who are pregnant or nursing
- Patients known to be HIV or hepatitis B or C positive or otherwise immunocompromised
- Patients with evidence of adrenal cortex abnormality or previous significant adverse reaction to intralesional steroids
- Patients unwilling or unable to discontinue treatments known to affect hair regrowth in alopecia areata
- Patients who have been treated with intralesional steroids, systemic steroids, anthralin, squaric acid, diphenylcyclopropenone (DPCP), protopic, minoxidil or other medication which in the opinion of the investigator may affect hair regrowth, within one month of the baseline visit
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01898806
Start Date
September 1 2011
End Date
January 1 2018
Last Update
June 6 2019
Active Locations (2)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
Columbia University Medical Center, Department of Dermatology
New York, New York, United States, 10032