Does Topical Steroid Treatment Impair the Adrenal Function?

Hypothalamus-Pituitary-Adrenal Axis Assessement Clinical Trial

Official title:

Low Dose (1mcg) ACTH Stimulation Test for Assessment of the Hypothalamo-Pituitary- Adrenal Axis in Patients Treated With Topical Corticosteroids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00476489
• Other study ID #: 02307EMC
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2007
• Last updated: May 21, 2007
• Start date: May 2007

Study information

• Verified date: May 2007
• Source: HaEmek Medical Center, Israel
• Contact: Avraham Ishay, MD
• Phone: 972-4-6495556
• Email: ishay_av[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypothalamus-Pituitary-Adrenal Axis Assessement
• Pituitary Diseases
• Skin Diseases
• Topical Steroid Therapy in Chronic Skin Diseases

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel,