Intralesional Steroids in the Treatment of Alopecia Areata

NCT01898806 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: AAAI5852
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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 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

Alopecia Areata

Keywords

Alopecia Areata; Kenalog; Triamcinolone

Outcome Measures

Primary Outcomes (1)

• Proportion of Responders

  Comparison of the proportion of responders in each group, with response defined as 50% change (% change NOT absolute change) in SALT score from baseline (50% regrowth at week 24).

  Up to 48 weeks

Secondary Outcomes (1)

• Number of Adverse Events

  48 weeks

Study Arms (4)

IL TAC 2.5 mg/ml

EXPERIMENTAL

Intralesional 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

Drug: Intralesional Triamcinolone 2.5 mg/ml

IL TAC 5 mg/ml

EXPERIMENTAL

Intralesional 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.

Drug: Intralesional Triamcinolone 5 mg/ml

IL TAC 10 mg/ml

EXPERIMENTAL

Intralesional 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.

Drug: Intralesional Triamcinolone 10 mg/ml

Placebo

PLACEBO COMPARATOR

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. 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.

Drug: Intralesional Saline

Interventions

Intralesional Triamcinolone 2.5 mg/ml DRUG

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.

Also known as: Kenalog, IL TAC 2.5 mg/ml

IL TAC 2.5 mg/ml

Intralesional Triamcinolone 5 mg/ml DRUG

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.

Also known as: Kenalog, IL TAC 5 mg/ml

IL TAC 5 mg/ml

Intralesional Triamcinolone 10 mg/ml DRUG

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.

Also known as: Kenalog, IL TAC 10 mg/ml

IL TAC 10 mg/ml

Intralesional Saline DRUG

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.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• University of Minnesota: collaborator

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Columbia University Medical Center, Department of Dermatology

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Grace Ulerio
• Organization: Columbia University

gu2102@cumc.columbia.edu

212-305-6953

Study Officials

• Julian Mackay-Wiggan, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 12, 2013
• Study Start: September 1, 2011
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)