A Psoriasis Plaque Test Study With LEO 90100 Cutaneous Spray, Ointment, in Psoriasis Vulgaris

Phase 2

Completed

Conditions: Psoriasis Vulgaris

Interventions: Drug: LEO90100 cutaneous spray, ointment
Drug: LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate
Drug: LEO 90100 cutaneous spray, ointment, vehicle
Drug: Daivobet® ointment

Registration Number: NCT01347255

Lead Sponsor: LEO Pharma

Brief Summary: The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous spray ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

Subjects having signed and dated an informed consent
Age 18 years or above
Either sex
All skin types
Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk.

Exclusion Criteria

Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer)for experimental biological products prior to randomisation and during the study
Systemic treatments 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 study
Use of phototherapy within the following time periods prior to randomisation and during the study:
- PUVA or Grenz ray therapy (4 weeks)
- UVB (2 weeks)
Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study:
- 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 study:
- 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)
- Anthracen derivatives
- Tar
- Salicylic acid
Subjects using emollients on the target plaques within one week before randomisation and during the study
Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study
Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history
Subjects with any of the following conditions present on the test area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin
Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas
History of any severe disease or serious current condition (based on subject interview and/or results of screening physical examination) which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course (e.g. cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency)
Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
Subjects with current participation in any other interventional clinical trial, based on interview of the subject
Subjects with known or suspected hypersensitivity to component(s) of the investigational products
Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit
Subjects impossible to contact in case of emergency
Subjects who are known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomisation
Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom
Subjects previously randomised in this trial

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LEO 90100 cutaneous spray ointment	LEO90100 cutaneous spray, ointment	LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone	LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate	Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
LEO 90100 Cutaneous Spray, Ointment, Vehicle	LEO 90100 cutaneous spray, ointment, vehicle	LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
Daivobet® Ointment	Daivobet® ointment	Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)

Primary Outcome Measures

Name	Time	Method
Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline	Day 1 (Baseline)/Day 29	TCS range from 0 (all signs absent) to 9 (all signs severe).

Secondary Outcome Measures

Name	Time	Method
Changes in Total Clinical Score (TCS) by Visit	Baseline and Days 4, 8, 11, 15, 18, 22, 25	Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline.
Change From Baseline in Echo-poor Band Thickness at End of Treatment	Baseline and Day 29	Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound
Change in Clinical Sign Scores	Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)	Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline. The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)). Negative changes in mean score represent improvement.
Changes in Total Skin Thickness	Baseline and Days 8, 15, 22, and 29.	Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline