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

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Psoriasis Vulgaris

Treatments: Drug: LEO 29102 cream; Drug: Daivobet® Ointment; Drug: LEO 29102 Plus Calcipotriol Cream; Drug: LEO 29102 Cream Vehicle; Drug: Betamethasone Dipropionate Cream; Drug: LEO 29102 Plus Betamethasone Dipropionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00875277

PLQ-003

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: (in summary)

• 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: (in summary)

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 6 patient groups, including a placebo group

LEO 29102 cream

Experimental group

Description:

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

Treatment:

Drug: LEO 29102 cream

LEO 29102 Cream Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: LEO 29102 Cream Vehicle

Betamethasone Dipropionate Cream

Experimental group

Description:

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

Treatment:

Drug: Betamethasone Dipropionate Cream

LEO 29102 Plus Calcipotriol Cream

Experimental group

Description:

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

Treatment:

Drug: LEO 29102 Plus Calcipotriol Cream

LEO 29102 Plus Betamethasone Dipropionate

Experimental group

Description:

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

Treatment:

Drug: LEO 29102 Plus Betamethasone Dipropionate

Daivobet® Ointment

Active Comparator group

Description:

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

Treatment:

Drug: Daivobet® Ointment