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Does Topical Steroid Treatment Impair the Adrenal Function?
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by HaEmek Medical Center, Israel.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
HaEmek Medical Center, Israel
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00476489
First received: May 21, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
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Purpose
The purpose of this study is to determine if topical steroids treatment for different skin diseases suppress the adrenal cortisol production.
| Condition |
|---|
| Hypothalamus-Pituitary-Adrenal Axis Assessement Topical Steroid Therapy in Chronic Skin Diseases |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Drug Information available for:
Epinephrine bitartrate
Epinephrine
Epinephrine hydrochloride
Racepinephrine hydrochloride
Racepinephrine
U.S. FDA Resources
Further study details as provided by HaEmek Medical Center, Israel:
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476489
Please refer to this study by its ClinicalTrials.gov identifier: 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
| ClinicalTrials.gov Identifier: | NCT00476489 History of Changes |
| Other Study ID Numbers: |
02307EMC |
| Study First Received: | May 21, 2007 |
| Last Updated: | May 21, 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 |
ClinicalTrials.gov processed this record on September 21, 2017