A Psoriasis Plaque Test Comparing Eight Different Formulations of Vitamin D Analogues for the Treatment of Psoriasis
- Conditions
- Psoriasis Vulgaris
- Interventions
- Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues
- Registration Number
- NCT01105286
- Lead Sponsor
- LEO Pharma
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Calcipotriol ointment Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues -
- Primary Outcome Measures
Name Time Method Total Clinical Score of clinical symptoms 4 weeks
- Secondary Outcome Measures
Name Time Method Clinical scores, lesions thickness 4 weeks
Trial Locations
- Locations (1)
LEO Pharma investigational site
🇫🇷Nice, France