LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Psoriasis Vulgaris

Treatments: Drug: LEO 90100 vehicle; Drug: Ointment vehicle; Drug: Betamethasone plus calcipotriol; Drug: LEO 90100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01536886

LEO 90100-35

Details and patient eligibility

About

The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus betamethasone are effective in the treatment of psoriasis vulgaris.

Enrollment: 376 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent obtained prior to any trial related activities (including washout period).
• Age 18 years or above
• Either sex
• Any race or ethnicity
• All skin types
• Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1).
• Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
• Able to communicate with the investigator and understand and comply with the requirements of the study.

Exclusion criteria

• 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
  • adalimumab, alefacept, infliximab - within 8 weeks prior to randomisation
  • ustekinumab - within 16 weeks prior to randomisation
  • other products - 4 weeks/5 half-lives (whichever is longer)

• Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to randomisation.

• Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.

• PUVA therapy within 4 weeks prior to randomisation.

• UVB therapy within 2 weeks prior to randomisation.

• Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc.) during the study.

• Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the study.

• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.

• Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers and wounds.

• Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis vulgaris.

• Known or suspected disorders of calcium metabolism associated with hypercalcaemia.

• Known or suspected severe renal insufficiency or severe hepatic disorders.

• Known or suspected hypersensitivity to component(s) of the investigational products.

• Current participation in any other interventional clinical study.

• Previously randomised in this study.

• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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376 participants in 4 patient groups, including a placebo group

LEO 90100 vehicle

Placebo Comparator group

Description:

Aerosol foam with no active ingredient

Treatment:

Drug: LEO 90100 vehicle

Betamethasone plus calcipotriol

Active Comparator group

Description:

Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment

Treatment:

Drug: Betamethasone plus calcipotriol

LEO 90100

Experimental group

Description:

LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)

Treatment:

Drug: LEO 90100

Ointment vehicle

Placebo Comparator group

Description:

Ointment with no active ingredients

Treatment:

Drug: Ointment vehicle