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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02416258
Other study ID # LP0113-1123
Secondary ID 2014-004759-30
Status Completed
Phase Phase 2
First received April 9, 2015
Last updated May 1, 2017
Start date April 2015
Est. completion date June 2015

Study information

Verified date May 2017
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LP0113 aerosol spray

Aerosol spray vehicle

LEO 90100 aerosol foam

Betamethasone dipropionate aerosol spray

Calcipotriol aerosol spray

Daivobet® gel


Locations

Country Name City State
France Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) Nice

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration) End of treatment compared to baseline - 4 weeks
Secondary Absolute change in single clinical sign score: erythema, scaling, infiltration End of treatment and individual visits compared to baseline - 4 weeks
Secondary Absolute Change in Total Clinical Score (TCS) Individual visits compared to baseline - 4 weeks
Secondary Absolute change in total skin thickness and echo-poor band thickness End of treatment compared to baseline - 4 weeks
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