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Does Topical Steroid Treatment Impair the Adrenal Function?

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ClinicalTrials.gov Identifier: NCT00476489
Recruitment Status : Unknown
Verified May 2007 by HaEmek Medical Center, Israel.
Recruitment status was:  Recruiting
First Posted : May 22, 2007
Last Update Posted : May 22, 2007
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

Study Description
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Brief Summary:
The purpose of this study is to determine if topical steroids treatment for different skin diseases suppress the adrenal cortisol production.

Condition or disease
Hypothalamus-Pituitary-Adrenal Axis Assessement Topical Steroid Therapy in Chronic Skin Diseases

Detailed Description:

Adrenocortical suppression is a potential complication of systemic corticosteroid treatement but also of non systemic therapy like topical therapy.

The normalcy of hypothalamic-pituitary-adrenal axis ( HPA axis) of patients with chronic skin diseases like atopic dermatitis, pemphigus or psoriasis which are treated with topical steroids, will be assessed with the low dose (1mcg) adrenocortocotropin ( ACTH) stimulation test. During this test serum cortisol levels are measured before, 30 and 60 mn after intravenous administration of 1mcg of ACTH (synacthen).The results will be compared with age and sex matched subjects with normal HPA axis as assessed by low dose ACTH stimulation test.


Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Low Dose (1mcg) ACTH Stimulation Test for Assessment of the Hypothalamo-Pituitary- Adrenal Axis in Patients Treated With Topical Corticosteroids
Study Start Date : May 2007

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients receiving daily topical steroids for at least two weeks on 10% or more of body surface.

Exclusion Criteria:

  • patients treated with any form of corticosteroids except topical steroids.
  • patients with known pituitary disease
  • pregnant patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476489


Contacts
Contact: Avraham Ishay, MD 972-4-6495556 ishay_av@clalit.org.il
Contact: Rafael Luboshitzky, MD r_luboshitzky@clalit.org.il

Locations
Israel
Haemek Medical Center Recruiting
Afula, Israel, 18101
Contact: Avraham Ishay, MD    972-4-6495556    ishay_av@clalit.org.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Avraham Ishay, MD haemek medical center
More Information
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ClinicalTrials.gov Identifier: NCT00476489     History of Changes
Other Study ID Numbers: 02307EMC
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: May 22, 2007
Last Verified: May 2007

Keywords provided by HaEmek Medical Center, Israel:
secondary adrenal insuffiency
hypothalamus-pituitary-adrenal axis impairement
topical steroids

Additional relevant MeSH terms:
Pituitary Diseases
Skin Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents