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Does Topical Steroid Treatment Impair the Adrenal Function?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
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
  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:

MedlinePlus related topics: Skin Conditions
U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Estimated Enrollment: 50
Study Start Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00476489     History of Changes
Other Study ID Numbers: 02307EMC
Study First Received: May 21, 2007
Last Updated: May 21, 2007
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013