Effect of Calcipotriol Plus Hydrocortisone Ointment on the Adrenal Hormone Balance and Calcium Me… (NCT00704262) | Clinical Trial Compass
CompletedPhase 2
Effect of Calcipotriol Plus Hydrocortisone Ointment on the Adrenal Hormone Balance and Calcium Metabolism in Patients With Psoriasis Vulgaris on the Face and Skin Folds
United States, Canada, Germany33 participantsStarted 2008-05
Plain-language summary
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to monitor the effect of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g on the hypothalamic-pituitary-adrenal axis and on the calcium metabolism in patients with psoriasis vulgaris on the face and on the intertriginous areas
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of psoriasis vulgaris involving the face and the intertriginous areas
* Clinical diagnosis of psoriasis vulgaris on the trunk and/or limbs or earlier diagnosed with psoriasis vulgaris on the trunk and/or limbs
* An extent of psoriatic involvement on the face of at least 5 cm2 and the sum of all facial and intertriginous lesions at least 30 cm2
* Treatment areas (face and intertriginous) amenable to topical treatment with a maximum of 100g ointment per week
* Disease severity of the face and intertriginous areas graded as moderate, severe or very severe according to the investigator´s global assessment of disease severity
* Patients with a normal HPA axis function: serum cortisol concentration above 5 mcg/dl before adrenocorticotropic hormone (ACTH: tetracosactid/cosyntropin) injection and serum cortisol concentration above 18 mcg/dl 30 min after ACTH (tetracosactid/cosyntropin) injection
* Albumin corrected serum calcium within reference range
* Females of childbearing potential have to use a highly effective method of contraception during the study (hormonal contraceptives on oestrogen basis are not allowed)
Exclusion Criteria:
* A history of active allergy, asthma, allergic skin rash, or sensitivity to any medication (including ACTH/tetracosactid/cosyntropin) or to any component of the formulations being tested
* Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (eg vitamin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 and 60 Minutes
Timeframe: At Week 4 (Day 28) and Week 8 (Day 56)
2
Change in Albumin Corrected Serum Calcium
Timeframe: From baseline to Week 4, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8)