Clinical trial NCT02416258: A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin and Connective Tissue Diseases
Keywords: Psoriasis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)
timeFrame: End of treatment compared to baseline - 4 weeks
Secondary outcomes:
measure: Absolute change in single clinical sign score: erythema, scaling, infiltration
timeFrame: End of treatment and individual visits compared to baseline - 4 weeks
measure: Absolute Change in Total Clinical Score (TCS)
timeFrame: Individual visits compared to baseline - 4 weeks
measure: Absolute change in total skin thickness and echo-poor band thickness
timeFrame: End of treatment compared to baseline - 4 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Study officials:
References: