Intralesional Steroids in the Treatment of Alopecia Areata

• Status: Terminated
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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 compared to treatment with placebo (sterile saline solution). After the 1st 6 months, nonresponders or partial responders may be treated for 6 months with open label triamcinolone at the dose deemed appropriate by the investigator.

The investigators will also perform skin biopsies of the scalp and draw blood at selected time points in order to examine the immunohistochemical/pathological response in scalp hair follicles and the systemic circulation to treatment with IL TAC for alopecia areata.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborators: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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