Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Psoriasis Vulgaris

Treatments: Drug: 0.1% betamethasone valerate ointment (class III steroid); Drug: LEO 134310; Drug: LEO 134310 vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03669757

LP0155-1375

2018-000140-26 (EudraCT Number)

Details and patient eligibility

About

To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.

Enrollment: 13 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects aged 18-64 years (inclusive) with plaque psoriasis in a chronic stable phase.
• Men or women of non-child bearing potential.

Exclusion criteria

• Acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.
• According to defined washout periods: topical antipsoriatic drugs (except salicylic acid in petroleum jelly); systemic antipsoriatics and biologics; ultraviolet (UV) therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 6 patient groups, including a placebo group

LEO 134310 Dose A

Experimental group

Description:

Once daily application

Treatment:

Drug: LEO 134310

Drug: LEO 134310

Drug: LEO 134310

Drug: LEO 134310

LEO 134310 Dose B

Experimental group

Description:

Once daily application

Treatment:

Drug: LEO 134310

Drug: LEO 134310

Drug: LEO 134310

Drug: LEO 134310

LEO 134310 Dose C

Experimental group

Description:

Once daily application

Treatment:

Drug: LEO 134310

Drug: LEO 134310

Drug: LEO 134310

Drug: LEO 134310

LEO 134310 Dose D

Experimental group

Description:

Once daily application

Treatment:

Drug: LEO 134310

Drug: LEO 134310

Drug: LEO 134310

Drug: LEO 134310

LEO 134310 vehicle

Placebo Comparator group

Description:

Once daily application

Treatment:

Drug: LEO 134310 vehicle

0.1% betamethasone valerate ointment (class III steroid)

Active Comparator group

Description:

Once daily application

Treatment:

Drug: 0.1% betamethasone valerate ointment (class III steroid)