ong-term treatment of Scalp Psoriasis with Calciptriol plus Betamethasone dipropionate gel.A phase III safety study of a new gel containing calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as dipropionate) used once daily, as needed, in scalp psoriasis.
- Conditions
- Psoriasis of the scalpExtent: Minimum 10% of the total scalp areaDisease severity: Graded as moderate, severe, or very severe according to the investigator's global assessment of disease severityClinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbsMedDRA version: 7.0Level: LLTClassification code 10037115
- Registration Number
- EUCTR2004-002861-19-GB
- Lead Sponsor
- EO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
1. Scalp psoriasis amenable to topical treatment with a maximum of 100 g of study medication 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. Disease severity on the scalp graded as Moderate, Severe or Very Severe according to the Investigator’s Global Assessment of disease severity
5. Patients aged 18 years or above
6. Patients may be of either sex
7. Patients may be of any ethic origin
8. 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
9. 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
10. Patients must fulfil all relevant national requirements/laws for participation in this study
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 Grentz ray therapy anywhere on the patient within 28 days prior to randomisation
2. UVB therapy anywhere on the patient within 14 days prior to randomisation
3. Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on, scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisation.
4. Systemic treatments with a potential effect on scalp psoriasis vulgaris (e.g. corticosteroids, retinoids, immunosuppressants) within 28 days prior to randomisation.
5. Any topical treatment for scalp psoriasis or any other skin disease on the scalp (excluding medicated shampoos, emollients and hair conditioners) within 14 days prior to randomisation
6. Topical treatment for other skin disorders with very potent WHO group IV corticosteroids within 14 days prior to randomisation.
7. Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis (e.g., beta blockers, antimalarial drugs, lithium) during the study
8. Current diagnosis of guttate, pustular, exfoliative or erythrodermic 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 severe renal insufficiency or severe hepatic disorders.
11. Patients with history/ signs/ symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia.
12. Known or suspected hypersensitivity to component(s) of the Investigational Products.
13. Current participation in any other interventional clinical trial.
14. 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 28 days prior to randomisation, or longer if the class of the substance requires a longer washout as defined above (e.g., biological treatments).
15. Previously enrolled / randomised in this trial
16. Patients known or suspected of not being able to comply with specifically a year-long trial design (e.g., due to alcoholism, drug dependency, psychotic state or general inability to make long term commitments).
17. Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the study, or are breast feeding.
18. 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. Trial subjects should be using an adequate method of contraception.)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the safety of once daily calcipotriol plus betamethasone dipropionate gel used, as needed, for up to 52 weeks for the treatment of scalp psoriasis.;Secondary Objective: To determine the efficacy of once daily calciptriol plus betamethasone dipropionate gel used, as needed, for the long-term treatment of scalp psoriasis (52 weeks) vs. once daily calcipotriol in same gel vehicle used, as needed for the long-term treatment of scalp psoriasis (52 weeks).;Primary end point(s): The primary end points will include the incidence of adverse drug reactions of any type and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.
- Secondary Outcome Measures
Name Time Method