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
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Condition or disease |
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Hypothalamus-Pituitary-Adrenal Axis Assessement Topical Steroid Therapy in Chronic Skin Diseases |
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 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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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Avraham Ishay, MD | 972-4-6495556 | ishay_av@clalit.org.il | |
Contact: Rafael Luboshitzky, MD | r_luboshitzky@clalit.org.il |
Israel | |
Haemek Medical Center | Recruiting |
Afula, Israel, 18101 | |
Contact: Avraham Ishay, MD 972-4-6495556 ishay_av@clalit.org.il |
Principal Investigator: | Avraham Ishay, MD | haemek medical center |
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 |