A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Skin and Connective Tissue Diseases

Treatments: Drug: LEO 90100 Aerosol foam; Drug: Betesil® 2.25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02518048

LP0053-1227

Details and patient eligibility

About

The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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35 participants in 2 patient groups

LEO 90100 Aerosol foam

Active Comparator group

Description:

Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)

Treatment:

Drug: LEO 90100 Aerosol foam

Betesil® 2.25 mg

Active Comparator group

Description:

Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone).(Betesil® )

Treatment:

Drug: Betesil® 2.25 mg