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Phase 2 Completed N=18 Screening

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

Source: ClinicalTrials.gov NCT00484679 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Mean Change in Cortisol Levels From Baseline to Week 24 — 0.187 mg/dL

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Change in Cortisol Levels From Baseline to Week 24
0.187

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00484679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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