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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

NCT ID: NCT03669757

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-27

Study Completion Date

2019-02-01

Brief Summary

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

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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

Intra-individual comparison of all treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The trial will be performed investigator-blind with random assignment of the 4 Investigational Medicinal Products (IMPs), the placebo and the active comparator.

Study Groups

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LEO 134310 Dose A

Once daily application

Group Type EXPERIMENTAL

LEO 134310

Intervention Type DRUG

Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

LEO 134310 Dose B

Once daily application

Group Type EXPERIMENTAL

LEO 134310

Intervention Type DRUG

Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

LEO 134310 Dose C

Once daily application

Group Type EXPERIMENTAL

LEO 134310

Intervention Type DRUG

Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

LEO 134310 Dose D

Once daily application

Group Type EXPERIMENTAL

LEO 134310

Intervention Type DRUG

Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

LEO 134310 vehicle

Once daily application

Group Type PLACEBO_COMPARATOR

LEO 134310 vehicle

Intervention Type DRUG

Active substance: none

0.1% betamethasone valerate ointment (class III steroid)

Once daily application

Group Type ACTIVE_COMPARATOR

0.1% betamethasone valerate ointment (class III steroid)

Intervention Type DRUG

Active substance: betamethasone valerate

Interventions

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LEO 134310

Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

Intervention Type DRUG

LEO 134310

Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

Intervention Type DRUG

LEO 134310

Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

Intervention Type DRUG

LEO 134310

Active substance: LEO 134310 is a compound in development at LEO Pharma A/S

Intervention Type DRUG

LEO 134310 vehicle

Active substance: none

Intervention Type DRUG

0.1% betamethasone valerate ointment (class III steroid)

Active substance: betamethasone valerate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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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Study Director

Role: STUDY_DIRECTOR

LEO Pharma

Locations

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Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status

Investigational Site

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2018-000140-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LP0155-1375

Identifier Type: -

Identifier Source: org_study_id

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