Intralesional Steroids in the Treatment of Alopecia Areata

• Sponsor: Columbia University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01898806
• Collaborator: University of Minnesota (Other)
• Enrollment: 11
• Locations: 2
• Arms: 4
• Actual Duration (Months): 76
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Drug: Intralesional Triamcinolone 2.5 mg/ml; Drug: Intralesional Triamcinolone 5 mg/ml; Drug: Intralesional Triamcinolone 10 mg/ml; Drug: Intralesional Saline	Phase 4

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.

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 a 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. The investigators currently do not have objective data on the frequency of occurrence of successful regrowth, the duration of response or the incidence of side effects. Intralesional triamcinolone (IL TAC) is 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 4 Multicenter, Randomized, Placebo Controlled Trial of 3 Doses of Intralesional Triamcinolone (KENALOG®) In the Treatment of Mild to Moderate Patch Type Alopecia Areata
• Actual Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IL TAC 2.5 mg/ml 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; 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.; Other Names: Kenalog IL TAC 2.5 mg/ml
Experimental: IL TAC 5 mg/ml 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; 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.; Other Names: Kenalog IL TAC 5 mg/ml
Experimental: IL TAC 10 mg/ml 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; 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.; Other Names: Kenalog IL TAC 10 mg/ml
Placebo Comparator: Placebo 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; 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.; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Proportion of Responders [Up to 48 weeks]

   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).

Secondary Outcome Measures

1. Number of Adverse Events [48 weeks]

   Incidence and severity of adverse events (AEs) including the presence and degree of skin atrophy, as well as incidence of treatment-emergent laboratory abnormalities.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455
2	Columbia University Medical Center, Department of Dermatology	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University
• University of Minnesota

Investigators

• Principal Investigator: Julian Mackay-Wiggan, MD, MS, Columbia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 20, 2015

More Information

Publications

None provided.

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT01898806
• Other Study ID Numbers: AAAI5852
• First Posted: Jul 12, 2013
• Last Update Posted: Jun 6, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Columbia University: Alopecia Areata; Kenalog; Triamcinolone
• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate

Study Results

Participant Flow

Pre-assignment Detail	Since the PI left the institution, the only data available at this time is information on the population enrolled that was provided to the IRB. Data was not provided to the IRB per arm, but rather, for as a collective whole

Arm/Group Title	All Participants
Arm/Group Description	Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo.
Period Title: Overall Study
STARTED	11
COMPLETED	8
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo. Since the PI left the institution, the only data available at this time is information on the population enrolled that was provided to the IRB. Data was not provided to the IRB per arm, but rather, for as a collective whole.
Overall Participants	11
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	11 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	8 72.7%
Male	3 27.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 9.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 9.1%
White	6 54.5%
More than one race	0 0%
Unknown or Not Reported	3 27.3%

Outcome Measures

1. Primary Outcome

Title	Proportion of Responders
Description	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).
Time Frame	Up to 48 weeks

Outcome Measure Data

Analysis Population Description

Data was not collected for this outcome since enrollment was incomplete and therefore could not be analyzed. The only information available is demographics data that was submitted to the IRB for the whole group, and not stratified per arm.

Arm/Group Title	All Participants
Arm/Group Description	Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo.
Measure Participants	0

2. Secondary Outcome

Title	Number of Adverse Events
Description	Incidence and severity of adverse events (AEs) including the presence and degree of skin atrophy, as well as incidence of treatment-emergent laboratory abnormalities.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo.
Measure Participants	8
Number [adverse events]	0

Adverse Events

Time Frame	2 years
Arm/Group Title	All Participants
Arm/Group Description	Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo. Data was not collected per arm, but rather, for as a collective whole.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.