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Intralesional Steroids in the Treatment of Alopecia Areata

Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alopecia Areata

Intervention: Triamcinolone 2.5 mg/ml (Drug); Triamcinolone 5 mg/ml (Drug); Triamcinolone 10 mg/ml (Drug); Intralesional Saline (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Columbia University

Official(s) and/or principal investigator(s):
Julian Mackay-Wiggan, MD, MS, Principal Investigator, Affiliation: Columbia University

Overall contact:
Julian Mackay-Wiggan, MD, MS, Phone: 212-305-6953, Email: jc299@columbia.edu

Summary

Alopecia areata is a common form of hair loss which reportedly occurs in up to 1. 7% of the population at some time in their life. Alopecia areata is apparently triggered when the individual's own immune system attacks hair follicles on the scalp or body resulting in hair loss ranging from single patches on the scalp (patch type alopecia areata) to loss of every hair on the scalp and body (alopecia universalis). Currently, there are limited treatment options for alopecia areata and unfortunately, the treatments utilized have never been rigorously tested in a placebo controlled trial. Triamcinolone (Kenalog) is a steroid solution that has been used as treatment for alopecia areata for over 50 years. It is administered via injection into the scalp and appears to have some efficacy for patients with mild to moderate alopecia areata. We currently do not have objective data on the frequency of occurrence of successful regrowth, the duration of response or the incidence of side effects. In addition, there is disagreement between clinicians regarding the dose of intralesional triamcinolone (IL TAC) that is considered most effective. 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 non or partial responders may be treated for 6 months with open label triamcinolone at the dose deemed appropriate by the investigator. We 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.

Clinical Details

Official title: A Phase 4 Multicenter, Randomized, Placebo Controlled Trial of 3 Doses of Intralesional Triamcinolone (KENALOGŪ) In the Treatment of Mild to Moderate Patch Type Alopecia Areata

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: SALT Score

Secondary outcome: Number of adverse events

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 psychological distress to affected individuals. AA affects more individuals than most other autoimmune diseases combined, including lupus erythematosus, type 1 diabetes, psoriasis, multiple sclerosis and rheumatoid arthritis. In contrast to these conditions, research into the pathogenesis and the development of innovative therapies in AA has lagged behind. Intralesional steroids (IL TAC) are arguably the most commonly used treatments for AA, especially in patients with less than 50% hair loss. Despite this, there are no adequately powered, randomized controlled clinical trials (RCTs) examining the efficacy, safety and duration of effect of IL TAC. In addition, the dosage or strength used varies among practitioners and the efficacy and safety of alternate doses of IL TAC has never been examined in a well designed RCT. Quantitative biomarkers for AA are a crucial step toward translational research aimed at clinical trials in AA. We will evaluate the efficacy of treating patients with moderate AA for 6mths with IL TAC at a strength of 2. 5mg/ml, 5mg/ml, IL TAC 10mg/ml versus intralesional saline (placebo) followed by a 6mth follow-up period to evaluate relapse and to identify a clinical correlation between treatment outcome and down modulation of key AA-associated immunohistopathological markers and biomarkers in the treated skin; including NKG2DL expression in the hair follicle, immune infiltration (CD8+NKG2D+ cells) and expression of interferon response genes. After the 1st 6 months non or partial responders may be treated with open label triamcinolone at the dose deemed appropriate by the investigator.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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) (2) 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, DPCP (diphenylcycloprophenone), protopic, minoxidil or other medication which in the opinion of the investigator may affect hair regrowth, within one month of the baseline visit.

Locations and Contacts

Julian Mackay-Wiggan, MD, MS, Phone: 212-305-6953, Email: jc299@columbia.edu

University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Maria Hordinsky, MD, Phone: 612-625-8625, Email: hordi001@umn.edu
Maria Hordinsky, MD, Principal Investigator

Columbia University Medical Center, Department of Dermatology, New York, New York 10032, United States; Recruiting
Julian Mackay-Wiggan, MD, MS, Phone: 212-305-6953, Email: jc299@columbia.edu
Grace Ulerio, Phone: 212-305-6953, Email: gu2102@columbia.edu
Julian Mackay-Wiggan, MD, MS, Principal Investigator

Additional Information

Starting date: September 2011
Last updated: February 3, 2015

Page last updated: August 23, 2015

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