Symptoms: Intensive itching, strictly deliminted, reddened and thickend skin areas
Age: 18+
Treatment: 4 weeks with gel
Which disease will be treated?
Psoriasis capitis (Psoriasis of scalp)
Strictly deliminted, reddened and thickend skin areas with frequent intensive itching are typical for Posiriasis captitis. The affected skin areas can also spread over to the hairless head section and can be visible at the forehead area, at the temples and in the neck. Affected people described the numerous visible scales as extremely onerous. Besides the scalp also other body areas can be affected.
TRIAL PHASE: III
DESIGN OF THE TRIAL:
Randomised – Double-blind – Placebo-controlled – Multicenter
Why will this trial be conducted?
In this clinical trial the efficacy and safety of a new gel containing 50 µg/g calcipotriol and 0.5 mg/g betamethasone vs. the originator Daivobet (R) Gel vs. vehicle in patients with psoriasis of the scalp will be evaluated.
Which treatment arms are given?
- Investigational product (Calcipotriol 50 μg/g_Betamethason 0,5 mg/g Gel)
- Comparator Daivobet® Gel (Calcipotriol 50 μg/g_Betamethason 0,5 mg/g Gel)
- Gel without active ingredient (Placebo)
Duration of the trial?
The treatment period is scheduled for 4 weeks with daily application.
WHO CAN PARTICIPATE IN THIS TRIAL?
Women and men of at least 18 years:
- with the diagnosis of Psoriasis involving at least 20% of the total scalp area
- with moderate expressed desquamation as well as consisting erythema of the scalp.
For women of childbearing potential:
Application of an efficient contraceptive method during the whole study and a pregnancy test with negative result prior to study start is necessary
WHO CANNOT PARTICIPATE IN THIS TRIAL?
Patients who did not met one of the following criteria:
- Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis
- Systemic therapy of psoriasis within the last 4 weeks before study inclusion
- Known intolerance or hypersensitivity against calcipotriol, betamethasone or other glucocorticoids or any of the other ingredients in the study medication
- Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
- Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster, varicella), fungal and bacterial skin infections, parasitic infections, skin manifestions in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds
- Other severe acute or chronic concomitant disease with severe impairment of the general condition
- Women with existing or intended pregnancy or during lactation
How many study sites will participate in this study in Germany?
15 sites