A Plaque Test Comparing the Anti-psoriatic Effect of Marketed Products for Topical Use for Psoriasis Vulgaris

NCT ID: NCT00845481

Last Updated: 2025-03-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-05-31

Brief Summary

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The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test

Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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all patients apply all products

Group Type EXPERIMENTAL

Daivobet® ointment

Intervention Type DRUG

Once daily application 6 days a week for 3 weeks

Betnovat® ointment

Intervention Type DRUG

Once daily application 6 days a week for 3 weeks

Diprosalic ointment

Intervention Type DRUG

Once daily application 6 days a week for 3 weeks

Dermovat ointment

Intervention Type DRUG

Once daily application 6 days a week for 3 weeks

Elocon ointment

Intervention Type DRUG

Once daily application 6 days a week for 3 weeks

Daivobet® ointment vehicle

Intervention Type DRUG

Once daily application 6 days a week for 3 weeks

Interventions

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Daivobet® ointment

Once daily application 6 days a week for 3 weeks

Intervention Type DRUG

Betnovat® ointment

Once daily application 6 days a week for 3 weeks

Intervention Type DRUG

Diprosalic ointment

Once daily application 6 days a week for 3 weeks

Intervention Type DRUG

Dermovat ointment

Once daily application 6 days a week for 3 weeks

Intervention Type DRUG

Elocon ointment

Once daily application 6 days a week for 3 weeks

Intervention Type DRUG

Daivobet® ointment vehicle

Once daily application 6 days a week for 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects having understood and signed an informed consent form
* All skin types
* Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable
* Subjects willing and able to follow all the study procedures and complete the whole study
* Subjects affiliated to social security system

Exclusion Criteria

* Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
* Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration
* Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
* Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - 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 (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy
* Subjects with skin manifestations 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 within the plaque test areas
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

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LEO Pharma Investigational Site

Saint Quentin Yvelines Cedex, , France

Site Status

Countries

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France

Related Links

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https://www.leopharmatrials.com/en

Clinical Trials at LEO Pharma

Other Identifiers

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PLQ-002

Identifier Type: -

Identifier Source: org_study_id

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