A Psoriasis Plaque Test Comparing Eight Different Formulations of Vitamin D Analogues for the Treatment of Psoriasis

LEO Pharma

Status and phase

Completed

Phase 1

Conditions

Psoriasis Vulgaris

Treatments

Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues

Study type

Interventional

Funder types

Industry

Identifiers

NCT01105286

2009-017393-20 (EudraCT Number)

PLQ-005

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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