CompletedPhase 1

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

Germany13 participantsStarted 2018-09-27

Plain-language summary

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

Who can participate

Age range18 Years – 64 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Overall number of treatment-emergent adverse events.

Timeframe: Up to Day 19

Number of treatment-emergent application site reactions, by treatment.

Timeframe: Up to Day 19

Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters

Timeframe: Up to Day 12

Change from baseline to Day 4, Day 8 and Day 12 in clinical chemistry parameters

Timeframe: Up to Day 12

Change from baseline to Day 4, Day 8 and Day 12 in urinalysis parameters

Timeframe: Up to Day 12

Number of subjects with abnormal clinical significant ECG evaluation

Timeframe: Up to Day 12

Number of subjects with abnormal clinically significant findings of physical examination at Day 12.

Timeframe: Up to Day 12

Change from baseline to Day 4, Day 8, Day 12 in systolic and diastolic blood pressure.

Trial details

NCT IDNCT03669757

SponsorLEO Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-02-01

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