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

• ClinicalTrials.gov Identifier: NCT00484679
• Recruitment Status: Completed
• First Posted: June 11, 2007
• Results First Posted: June 20, 2014
• Last Update Posted: June 29, 2018
• Sponsor: University of Minnesota
• Collaborator: National Alopecia Areata Foundation
• Information provided by (Responsible Party): University of Minnesota

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Alopecia Areata	Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata
• Study Start Date: May 2007
• Actual Primary Completion Date: June 2009
• Actual Study Completion Date: March 2011

Arms and Interventions

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 Name: Kenalog 10

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

National Alopecia Areata Foundation

Investigators

• Study Director: Maria K Hordinsky, MD; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT00484679
• Other Study ID Numbers: 0609M91989
• First Posted: June 11, 2007
• Results First Posted: June 20, 2014
• Last Update Posted: June 29, 2018
• Last Verified: April 2017

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action