Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL in Patients With Alopecia Areata - NCT00484679-55455 (Clinical Trial 171887)
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| City: |
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Minneapolis |
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State:
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MN |
| Zip Code: |
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55455 |
| Conditions: |
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Alopecia Areata |
| Purpose: |
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The purpose of the study is to see whether treating alopecia areata with injections of the
corticosteroid, Kenalog-10, has an impact on the adrenal glands.
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| Study summary: |
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1. To determine the effects of intralesional Kenalog 10 use for the treatment of alopecia
areata on adrenal function.
2. To evaluate the efficacy of intralesional corticosteroids on hair regrowth in moderate
to severe alopecia areata.
Approximately 30 subjects with moderate to severe alopecia areata will be enrolled.
Subjects will undergo intralesional triamcinolone acetonide (10mg/cc) injections every 6
weeks for a period of 6 months in the General Clinical Research Center (GCRC). This period
will be followed by a 6 week, injection-free, safety follow-up visit. Adrenal function will
be 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 will be done at baseline and 6-week intervals at the start
of each scheduled appointment for intralesional treatment at approximately 0800 hours. Two
blood draws will be taken at time 0 and again 30 minutes after a 1 mcg bolus dose of
synthetic ACTH (Cortrosyn).
Patients will undergo their scheduled course of intralesional corticosteroid injections and
other study data will be collected, such as SALT scores and physician assessments of AA,
during the time between blood draws. |
| Criteria: |
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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 Kenalog 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. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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January 19, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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