A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products

NCT ID: NCT00875277

Last Updated: 2025-03-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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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

2009-04-30

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.

Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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LEO 29102 cream

LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks

Group Type EXPERIMENTAL

LEO 29102 cream

Intervention Type DRUG

LEO 29102 Cream Vehicle

LEO 29102 cream vehicle applied topically twice daily for 4 weeks.

Group Type PLACEBO_COMPARATOR

LEO 29102 Cream Vehicle

Intervention Type DRUG

Betamethasone Dipropionate Cream

Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.

Group Type EXPERIMENTAL

Betamethasone Dipropionate Cream

Intervention Type DRUG

LEO 29102 Plus Calcipotriol Cream

LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.

Group Type EXPERIMENTAL

LEO 29102 Plus Calcipotriol Cream

Intervention Type DRUG

LEO 29102 Plus Betamethasone Dipropionate

LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.

Group Type EXPERIMENTAL

LEO 29102 Plus Betamethasone Dipropionate

Intervention Type DRUG

Daivobet® Ointment

Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.

Group Type ACTIVE_COMPARATOR

Daivobet® Ointment

Intervention Type DRUG

Interventions

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LEO 29102 cream

Intervention Type DRUG

LEO 29102 Cream Vehicle

Intervention Type DRUG

Betamethasone Dipropionate Cream

Intervention Type DRUG

LEO 29102 Plus Calcipotriol Cream

Intervention Type DRUG

LEO 29102 Plus Betamethasone Dipropionate

Intervention Type DRUG

Daivobet® Ointment

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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Director, International Clinical Development, MD

Role: STUDY_DIRECTOR

LEO Pharma

Locations

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LEO Pharma site

Saint-Quentin-en-Yvelines, , France

Site Status

Countries

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France

Other Identifiers

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PLQ-003

Identifier Type: -

Identifier Source: org_study_id

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