Psoriasis Vulgaris
Conditions
Brief summary
The purpose of this trial is to compare the anti-psoriatic effect of eight different formulations of vitamin D analogues using a psoriasis plaque test design
Interventions
DRUGSix different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues
Once daily application
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects having understood and signed an informed consent form. * Either sex * Age 18 years or above * All skin types and any ethnic origin * Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk.
Exclusion criteria
* Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding * Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation * Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 4-week period prior to randomisation * Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study: * Potent or very potent (WHO group III-IV) corticosteroids * PUVA or Grenz ray therapy * Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study: * WHO group I-II corticosteroids (except if used for treatment of scalp psoriasis) * Topical retinoids * Vitamin D analogues * Topical immunomodulators (e.g. macrolides) * Anthracen derivatives * Tar * Salicylic acid * UVB therapy * Subjects known to be non-responder to topical vitamin D analogues (e.g., known history of no improvement or worsening of psoriasis with e.g., calcipotriol, calcitriol or tacalcitol when used according to current SmPc) * Subjects 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 the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments) * Subjects with current participation in any other interventional clinical, based on interview of the subject * Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis * Subjects with known or suspected hypersensitivity to component(s) of the investigational products * Subjects with known/suspected disorders of calcium metabolism associated with hypercalcaemia * Subjects with known severe hepatic and/or severe renal insufficiency * Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Clinical Score of clinical symptoms | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Clinical scores, lesions thickness | 4 weeks |
Countries
France
Outcome results
None listed