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

NCT00484679 | Completed Phase 2 Results

• 1 other identifier: 0609M91989
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

Patients receiving Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections.

Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)

Interventions

Triamcinolone Acetonide 10 mg/mL (Kenalog-10) DRUG

Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection

Also known as: Kenalog 10

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• National Alopecia Areata Foundation: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Maria Hordinsky, MD
• Organization: University of Minnesota

hordi001@umn.edu

612-624-5721

Study Officials

• Maria K Hordinsky, MD

  University of Minnesota

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2007
• First Posted: June 11, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: March 1, 2011
• Last Updated: June 29, 2018
• Results First Posted: June 20, 2014

Record last verified: 2017-04

Locations

US (1)