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A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123) (LP0113-1123)

Primary Purpose

Skin and Connective Tissue Diseases

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

LP0113 aerosol spray

Aerosol spray vehicle

LEO 90100 aerosol foam

Betamethasone dipropionate aerosol spray

Calcipotriol aerosol spray

Daivobet® gel

About this trial

This is an interventional treatment trial for Skin and Connective Tissue Diseases focused on measuring Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed and dated informed consent has been obtained
Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.
Age 18 years or above
Outpatients
Female subjects must be of either
- non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or,
- child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.

Exclusion Criteria:

Female subjects who are breast feeding
Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- Etanercept - within 4 weeks prior to randomisation and during the trial
- Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial
- Ustekinumab - within 16 weeks prior to randomisation and during the trial
- Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer)
Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial,
Subjects using phototherapy within the following time periods prior to randomisation and during the trial:
- PUVA: 4 weeks
- UVB: 2 weeks
Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:
- Potent or very potent (WHO group III-IV) corticosteroids
Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial:
- WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
- Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid
Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial
Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

Sites / Locations

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

LP0113 aerosol spray

Aerosol spray vehicle

LEO 90100 aerosol foam

Betamethasone dipropionate aerosol spray

Calcipotriol aerosol spray

Daivobet® gel

Arm Description

Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical

No active ingredient, topical

Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical

Betamethasone (as dipropionate) 0.5 mg/g, topical

Calcipotriol (as monohydrate) 50 mcg/g, topical

Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical

Outcomes

Primary Outcome Measures

Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)

Secondary Outcome Measures

Absolute change in single clinical sign score: erythema, scaling, infiltration

Absolute Change in Total Clinical Score (TCS)

Absolute change in total skin thickness and echo-poor band thickness

Full Information

NCT ID

NCT02416258

First Posted

April 9, 2015

Last Updated

May 1, 2017

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT02416258

Brief Title

A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123)

Acronym

LP0113-1123

Official Title

A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LP0113 Aerosol Spray Compared With Its Vehicle and With Daivobet® Gel, LEO 90100 Aerosol Foam, Betamethasone Dipropionate Aerosol Spray and Calcipotriol Aerosol Spray in the Treatment of Psoriasis Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin and Connective Tissue Diseases

Keywords

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LP0113 aerosol spray

Arm Type

Active Comparator

Arm Description

Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical

Arm Title

Aerosol spray vehicle

Arm Type

Placebo Comparator

Arm Description

No active ingredient, topical

Arm Title

LEO 90100 aerosol foam

Arm Type

Active Comparator

Arm Description

Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical

Arm Title

Betamethasone dipropionate aerosol spray

Arm Type

Active Comparator

Arm Description

Betamethasone (as dipropionate) 0.5 mg/g, topical

Arm Title

Calcipotriol aerosol spray

Arm Type

Active Comparator

Arm Description

Calcipotriol (as monohydrate) 50 mcg/g, topical

Arm Title

Daivobet® gel

Arm Type

Active Comparator

Arm Description

Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical

Intervention Type

Drug

Intervention Name(s)

LP0113 aerosol spray

Intervention Type

Drug

Intervention Name(s)

Aerosol spray vehicle

Intervention Type

Drug

Intervention Name(s)

LEO 90100 aerosol foam

Intervention Type

Drug

Intervention Name(s)

Betamethasone dipropionate aerosol spray

Intervention Type

Drug

Intervention Name(s)

Calcipotriol aerosol spray

Intervention Type

Drug

Intervention Name(s)

Daivobet® gel

Primary Outcome Measure Information:

Title

Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)

Time Frame

End of treatment compared to baseline - 4 weeks

Secondary Outcome Measure Information:

Title

Absolute change in single clinical sign score: erythema, scaling, infiltration

Time Frame

End of treatment and individual visits compared to baseline - 4 weeks

Title

Absolute Change in Total Clinical Score (TCS)

Time Frame

Individual visits compared to baseline - 4 weeks

Title

Absolute change in total skin thickness and echo-poor band thickness

Time Frame

End of treatment compared to baseline - 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed and dated informed consent has been obtained Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products. Age 18 years or above Outpatients Female subjects must be of either non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or, child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy. Exclusion Criteria: Female subjects who are breast feeding Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation: Etanercept - within 4 weeks prior to randomisation and during the trial Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial Ustekinumab - within 16 weeks prior to randomisation and during the trial Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer) Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial, Subjects using phototherapy within the following time periods prior to randomisation and during the trial: PUVA: 4 weeks UVB: 2 weeks Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial: Potent or very potent (WHO group III-IV) corticosteroids Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial: WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis) Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

Facility Information:

Facility Name

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

City

Nice

ZIP/Postal Code

06000

Country

France

12. IPD Sharing Statement

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A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123)

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