Psoriasis of the scalp Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs Extent of scalp psoriasis involving 10% or more of the total scalp area Disease severity on the scalp graded as at least "moderate" according to the investigator’s global assessment of disease severity MedDRA version: 7.0 Level: LLT Classification code 10037115
Conditions
Interventions
Product Name: DAIVOBET/DOVOBET gel
Pharmaceutical Form: Gel
INN or Proposed INN: Calcipotriol
CAS Number: 147657-22-5
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentr
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is carried out, including washout 2. Scalp psoriasis amenable to topical treatment with a maximum of 100 g DAIVOBET/DOVOBET gel or 60 ml DAIVONEX/DOVONEX scalp solution per week 3. Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs 4. Extent of scalp psoriasis involving 10% or more of the total scalp area 5. Investigator’s assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, redness, thickness and scaliness, and at least 1 in each of the other two clinical signs 6. Disease severity on the scalp graded as at least moderate according to the investigator’s global assessment of disease severity 7. Patients aged 18 years or above 8. Either sex 9. Any ethnic origin 10. Attending a hospital out-patient clinic or the private practice of a dermatologist 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
Exclusion criteria
Exclusion criteria: 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, immunosuppressants) within 4 weeks prior to randomisation 5. Any topical treatment of the scalp (except for non steroid 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 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 registration) within a month prior to randomisation, except for biologicals (6 months) 16. Previously randomised 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 baseline (day 0) (all females of child-bearing potential must have a pregnancy test at baseline and should fur-thermore be willing to use an adequate method of contraception during the study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To investigate the occurence of and time to relapse and occurence of rebound after end of treatment in patients with "Controlled" disease in a period of at least 8 weeks. To compare the safety of calcipotriol plus betamethasone dipropionate gel treatment with DAIVONEX/DOVONEX scalp solution treatment. To compare the quality of life in calcipotriol plus betamethasone dipropionate gel treatment with DAIVONEX/DOVONEX scalp solution treatment, using quality of life questionnaires during the treatment period. ;Main Objective: To compare the efficacy of 8 weeks, once daily treatment of calcipotriol plus betamethasone dipropionate gel with twice daily treatment of DAIVONEX/DOVONEX scalp solution, in the treatment of scalp psoriasis. ;Primary end point(s): The primary end point will include patients with "Controlled disease" ("Clear" or "Minimal" disease) according to the investigator’s global assessment of disease severity at the end of treatment. | — |
Countries
Belgium, Denmark, Sweden
Outcome results
None listed