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Intralesional Steroids in the Treatment of Alopecia Areata

NCT01898806 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-06-06

Study results available
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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.

Conditions

Interventions

DRUG

Intralesional Triamcinolone 2.5 mg/ml

Intralesional Triamcinolone at a strength of 2.5 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months.

DRUG

Intralesional Triamcinolone 5 mg/ml

Intralesional Triamcinolone at a strength of 5 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months.

DRUG

Intralesional Triamcinolone 10 mg/ml

Intralesional Triamcinolone at a strength of 10 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months.

DRUG

Intralesional Saline

Intralesional Saline (Placebo). Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss for a total of 6 months.

Sponsors & Collaborators

Principal Investigators

  • Julian Mackay-Wiggan, MD, MS · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2018-01-31
Completion
2018-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01898806 on ClinicalTrials.gov