A Psoriasis Plaque Test Comparing Products for the Treatment of Psoriasis Vulgaris

NCT ID: NCT01043224

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-03-31

Brief Summary

The purpose of this trial is to compare the anti-psoriatic effect of a topical combination product containing clobetasol propionate and calcipotriol in an ointment formulation to the single components in the same vehicle using a psoriasis plaque test design.

Conditions

Psoriasis Vulgaris

Study Design

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

Study Groups

Clobetasol propionate plus calcipotriol

Group Type: EXPERIMENTAL

Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicle

Intervention Type: DRUG

Once daily application

Interventions

Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicle

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 (ustekinmab) 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

• 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 2 weeks prior to randomisation

• WHO group I-II corticosteroids
• Topical retinoids
• Vitamin D analogues
• Topical immunomodulators (e.g. macrolides)
• Anthracen derivatives
• Tar
• Salicylic acid
• UVB therapy
• 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 of the following conditions present on the plaque test areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin
• Subjects with skin manifestations on the plaque test areas in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
• 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

EudractCT No: 2009-012139-14

Identifier Type: REGISTRY

Identifier Source: secondary_id

PLQ-004

Identifier Type: -

Identifier Source: org_study_id