Calcipotriol plus Betamethasone Dipropionate Gel Compared to Calcipotriol in the Gel Vehicle and Betamethasone Dipropionate in the Gel Vehicle in Scalp Psoriasis.A phase III study comparing a gel containing calcipotriol 50 mcg/g plus betamethasone dipropionate 0.5 mg/g (as dipropionate) with calcipotriol 50 mcg/g in the gel vehicle and betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, all applied once daily in the treatment of scalp psoriasis.
- Conditions
- Scalp psoriasis with 10% involvement of the scalpMedDRA version: 7.0Level: LLTClassification code 10037157
- Registration Number
- EUCTR2004-002152-33-FI
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1. Scalp psoriasis amenable to topical treatment with a maximum of 100 g of medica-tion per week
2. Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
3. Extent of scalp psoriasis involving more than 10% of the total scalp area
4. Investigator’s assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs
5. Disease severity on the scalp graded as Moderate, Severe or Very severe ac-cording to the investigator’s global assessment of disease severity
6. Patients aged 18 years or above
7. Either sex
8. Any ethnic origin
9. Attending a hospital out-patient clinic, the private practice of a dermatologist or the practice of a general practitioner experienced in the handling of psoriasis vulgaris
10. Following receipt of verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is car-ried out, including washout
11. Patients fulfilling national requirements/law for participation in this study
6.Patients aged 18 years or above
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. PUVA or Grenz ray therapy within 4 weeks prior to randomisation
2. UVB therapy within 2 weeks prior to randomisation
3. Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisation
4. Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosup-pressants) within 4 weeks prior to randomisation
5. Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation
6. Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
7. Planned initiation of, or changes to concomitant medication that could affect scalp psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the study
8. Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
9. Patients with any of the following conditions present on the scalp area: Viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
10. Known or suspected abnormality of the calcium homeostasis associated with clinically significant hypercalcaemia
11. Known or suspected severe renal insufficiency or severe hepatic disorders
12. Planned exposure to sun during the study, that may affect scalp psoriasis
13. Known or suspected hypersensitivity to component(s) of the Investigational Products
14. Current participation in any other interventional clinical study
15. Patients who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registra-tion) within a month prior to randomisation
16. Previously randomised and having received at least one treatment application in this study
17. Patients known or suspected of not being able to comply with a trial protocol (e.g., due to alcoholism, drug dependency or psychotic state)
18. Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the study, or are breast feeding
19. Females of child-bearing potential with positive pregnancy test at Visit 1 (all females of child-bearing potential must have a pregnancy test at Visit 1 and should further-more be willing to use an adequate method of contraception during the study)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the clinical efficacy of once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, and calcipotriol in the gel vehicle in patients with scalp psoriasis.<br><br>;Secondary Objective: To compare the safety of once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel with calcipotriol in the gel vehicle, and betamethasone dipropionate in the gel vehicle in patients with scalp psoriasis.<br>Safety will be assessed in terms of incidence and severity of adverse events, reasons for withdrawal from the study and change in serum calcium values from baseline to subsequent tests and after 7 and 28 days of treatment.<br>;Primary end point(s): Patients with ”Controlled disease” (Absence of disease” or Very mild disease”) according to investi-gator’s global assessment of disease severity at end of treatment.
- Secondary Outcome Measures
Name Time Method