Hypothalamus-Pituitary-Adrenal Axis AssessementNCT00476489
Does Topical Steroid Treatment Impair the Adrenal Function?
An observational study of Hypothalamus-Pituitary-Adrenal Axis Assessement and Topical Steroid Therapy in Chronic Skin Diseases, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The purpose of this study is to determine if topical steroids treatment for different skin diseases suppress the adrenal cortisol production. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypothalamus-Pituitary-Adrenal Axis Assessement, Topical Steroid Therapy in Chronic Skin Diseases
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- May 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients receiving daily topical steroids for at least two weeks on 10% or more of body surface.
Who cannot join
- patients treated with any form of corticosteroids except topical steroids.
- patients with known pituitary disease
- pregnant patients
Trial locations and contacts
1 site in 1 country.
Rafael Luboshitzky, MD contact
Israel1 site, 1 recruiting
- Recruiting
Haemek Medical Center
Afula, 18101
Avraham Ishay, MD, 972-4-6495556, ishay_av@clalit.org.il
About this study
Official title: Low Dose (1mcg) ACTH Stimulation Test for Assessment of the Hypothalamo-Pituitary- Adrenal Axis in Patients Treated With Topical Corticosteroids
The purpose of this study is to determine if topical steroids treatment for different skin diseases suppress the adrenal cortisol production.
Read the 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.
- Conditions
- Hypothalamus-Pituitary-Adrenal Axis Assessement, Topical Steroid Therapy in Chronic Skin Diseases
- Keywords
- secondary adrenal insuffiency, hypothalamus-pituitary-adrenal axis impairement, topical steroids
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothalamus-Pituitary-Adrenal Axis AssessementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Avraham Ishay, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476489
- Sponsor's protocol ID
- 02307EMC
- Status last verified
- May 2007
- First submitted
- 21 May 2007
- Last updated
- 22 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose (1mcg) ACTH Stimulation Test for Assessment of the Hypothalamo-Pituitary- Adrenal Axis in Patients Treated With Topical Corticosteroids
- ClinicalTrials.gov ID
- NCT00476489
- Acronym / sponsor ID
- 02307EMC
- Conditions
- Hypothalamus-Pituitary-Adrenal Axis Assessement, Topical Steroid Therapy in Chronic Skin Diseases
- Keywords
- secondary adrenal insuffiency, hypothalamus-pituitary-adrenal axis impairement, topical steroids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2007
- First posted
- 22 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if topical steroids treatment for different skin diseases suppress the adrenal cortisol production.
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
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients receiving daily topical steroids for at least two weeks on 10% or more of body surface.
Key exclusion criteria (3 listed)
- patients treated with any form of corticosteroids except topical steroids.
- patients with known pituitary disease
- pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Luboshitzky, MD contact
Avraham Ishay, MD principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothalamus-Pituitary-Adrenal Axis Assessement and Topical Steroid Therapy in Chronic Skin Diseases, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avraham Ishay, MD (972-4-6495556, ishay_av@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2007.