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

NCT ID: NCT01105286

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-06-30

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

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Calcipotriol ointment

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Once daily application

Interventions

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

Once daily application

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrice Facy, PhD

Role: STUDY_DIRECTOR

LEO Pharma

Locations

LEO Pharma investigational site

Nice, , France

Countries

France

Other Identifiers

2009-017393-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PLQ-005

Identifier Type: -

Identifier Source: org_study_id