Clinical trial NCT02518048: A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris
Official title: A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LEO 90100 Aerosol Foam Compared to Betesil® Medicated Plaster 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: 2015-08-07
Enrollment: 35
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 LEO 90100 aerosol foam compared with Betesil® medicated plaster

Detailed description: The products will be applied on 6 test sites (each product on 3 test sites) once daily 6 days a week (except Sundays) for 4 weeks. The application sites for each product will be determined according to random assignment. Depending on the size of the psoriasis plaques, 2 or 4 test sites will be located within the same plaque; the treatment assignment will be done pair-wise.

Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent has been obtained
* Subjects with a diagnosis of psoriasis vulgaris with preferably three lesions (plaques) located on arms, legs and/or trunk or at least two lesions (plaques) located on arms, legs and/or trunk. For subjects with three lesions, each lesion must have a size suitable to accommodate 2 test sites (test site area 5 cm2, distance between two test sites at least 2 cm). For subjects with two lesions, one lesion must have a size suitable to accommodate 4 test sites, and the other lesion must accommodate 2 test sites.
* 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, Infiltration) Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, and Infiltration) at End of Treatment Compared to Baseline
timeFrame: Day 1 (Baseline) to Day 29
Secondary outcomes:
measure: Change in TCS at Individual Visits
timeFrame: Day 1 (Baseline) to Day 29
measure: Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
timeFrame: Day 1 (Baseline) to Day 29
measure: Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT
timeFrame: Baseline to End of Treatment
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Study officials:
References:
citation: Queille-Roussel C, Rosen M, Clonier F, Norremark K, Lacour JP. Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam Compared with Betamethasone 17-Valerate-Medicated Plaster for the Treatment of Psoriasis. Clin Drug Investig. 2017 Apr;37(4):355-361. doi: 10.1007/s40261-016-0489-5.