Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata

The purpose of the study is to see whether treating alopecia areata with injections of the corticosteroid, Triamcinolone acetonide 10mg/cc (Kenalog-10), has an impact on the adrenal glands.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)

Detailed Description

1. To determine the effects of intralesional Triamcinolone Acetonide 10mg/cc (Kenalog 10) use for the treatment of alopecia areata on adrenal function.
2. To evaluate the efficacy of intralesional corticosteroids (Kenalog-10)on hair regrowth in moderate to severe alopecia areata.

18 subjects with moderate to severe alopecia areata were enrolled and 15 subjects completed all study visits.

Subjects underwent intralesional triamcinolone acetonide (10mg/cc) (Kenalog-10) injections every 6 weeks for a period of 6 months in the General Clinical Research Center (GCRC). This period was followed by a 6 week, injection-free, safety follow-up visit. Adrenal function was assessed by utilization of the Low Dose Adrenocorticotropic Hormone Stimulation Test (ACTH) which measures adrenal gland production of cortisol after exogenously administered ACTH. Serum blood draws of 3 mL were done at baseline and 6-week intervals at the start of each scheduled appointment for intralesional treatment at approximately 0800 hours. Two blood draws were taken at time 0 and again 30 minutes after a 1 mcg bolus dose of synthetic ACTH (Cortrosyn).

Patients underwent their scheduled course of intralesional corticosteroid (Kenalog-10) injections and other study data was collected, such as SALT scores and physician assessments of AA, during the time between blood draws.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has clinical diagnosis of alopecia areata.

• Written informed consent and HIPAA authorization have been obtained.

  • Female subjects of childbearing potential have a negative pregnancy test and agree to use an acceptable method of birth control to prevent pregnancy.
• In the opinion of the investigator, subject is a candidate for intralesional therapy for alopecia areata.
• Subject agrees to comply with protocol requirements and attend all required study visits and is considered to be a good study subject.
• Subject meets concomitant medication washout requirements.
• Subject is >/= 18 years of age.

Exclusion Criteria:

• Subject has alopecia universalis.
• Subject has known adrenocortical insufficiency or Cushing's Syndrome.
• Subject is pregnant or lactating.
• Subject has current controlled or uncontrolled bacterial, viral, fungal, atypical, or opportunistic infections.
• Subject possesses hypersensitivity to cortrosyn or Triamcinolone Acetonide (Kenalog-10) or any component of their formulation.
• Subject is currently or has undergone therapy for malignancy within the past five years.
• Subject has history of substance abuse within the past five years.
• Subject has used oral corticosteroids within the past 12 months.
• Subject has concurrent use of phenytion rifampin, phenobarbital, mitotane, or other formulations of corticosteroid medications.
• Subject has any medical condition that, in the judgement of the investigator, would jeopardize the subject's safety following exposure to the administered medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Patients receiving Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections.	Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10); Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection; Other Names: Kenalog 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Cortisol Levels From Baseline to Week 24	Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.	baseline, week 24

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Alopecia Areata Foundation
• Investigators: Study Director: Maria K Hordinsky, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: June 8, 2007
• First Submitted That Met QC Criteria: June 8, 2007
• First Posted (Estimate): June 11, 2007

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 0609M91989

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No