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Alopecia Areata | Intralesional Steroids in the Treatment of Alopecia Areata

Alopecia Areata research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Alopecia Areata

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Intralesional Triamcinolone 2.5 mg/mlIntralesional 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/mlIntralesional 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/mlIntralesional 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 SalineIntralesional 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

IL TAC 2.5 mg/mlIntralesional Triamcinolone 2.5 mg/ml (IL TAC 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. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20

IL TAC 5 mg/mlIntralesional Triamcinolone 5mg/ml (IL TAC 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. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20.

IL TAC 10 mg/mlIntralesional Triamcinolone 10mg/ml (IL TAC 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. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20.

PlaceboIntralesional 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. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20. Open label treatment with IL kenalog at the dose deemed most appropriate may be administered after the 1st 6 months in nonresponders or partial responders.

Study Status

Terminated

Start Date: September 2011

Completed Date: January 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Proportion of Responders

Secondary Outcome: Number of Adverse Events

Study sponsors, principal investigator, and references

Principal Investigator: Julian Mackay-Wiggan, MD, MS

Lead Sponsor: Columbia University

Collaborator: University of Minnesota - Clinical and Translational Science Institute

More information:https://clinicaltrials.gov/show/NCT01898806

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