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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02416258
Date of registration: 09/04/2015
Prospective Registration: No
Primary sponsor: LEO Pharma
Public title: A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123) LP0113-1123
Scientific 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
Date of first enrolment: April 2015
Target sample size: 50
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02416258
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Single (Investigator).  
Phase:  Phase 2
Countries of recruitment
France
Contacts
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Skin and Connective Tissue Diseases
Intervention(s)
Drug: Calcipotriol aerosol spray
Drug: LEO 90100 aerosol foam
Drug: Daivobet® gel
Drug: LP0113 aerosol spray
Drug: Aerosol spray vehicle
Drug: Betamethasone dipropionate aerosol spray
Primary Outcome(s)
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(s)
Absolute change in total skin thickness and echo-poor band thickness [Time Frame: End of treatment compared to baseline - 4 weeks]
Absolute Change in Total Clinical Score (TCS) [Time Frame: Individual visits compared to baseline - 4 weeks]
Absolute change in single clinical sign score: erythema, scaling, infiltration [Time Frame: End of treatment and individual visits compared to baseline - 4 weeks]
Secondary ID(s)
LP0113-1123
2014-004759-30
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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