LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

Last updated: February 21, 2025
Sponsor: LEO Pharma
Overall Status: Completed

Phase

3

Condition

Rosacea

Psoriasis And Psoriatic Disorders

Warts

Treatment

LEO 90100 aerosol foam

Aerosol foam vehicle

Gel vehicle

Clinical Study ID

NCT02132936
LP0053-1003
  • Ages > 18
  • All Genders

Study Summary

The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or above

  • Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitalsand skin folds) involving 2-30% of the Body Surface Area (BSA)

  • A Physician's Global Assessment of disease severity (PGA) of at least mild on trunkand limbs

  • A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk andlimbs.

Exclusion

Exclusion Criteria:

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

  • Systemic treatment with biological therapies, whether marketed or not, with apossible effect on psoriasis vulgaris within the following time periods prior torandomisation:

  • etanercept - within 4 weeks prior to randomisation

  • adalimumab, infliximab - within 8 weeks prior to randomisation

  • ustekinumab - within 16 weeks prior to randomisation

  • other products - within 4 weeks/5 half-lives prior to randomisation (whicheveris longer)

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

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

  • Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior torandomisation

  • Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation

  • Topical anti-psoriatic treatment on the trunk and limbs (except for emollients)within 2 weeks prior to randomisation

  • Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin Danalogues or prescription shampoos within 2 weeks prior to randomisation

  • Females who are pregnant, wishing to become pregnant during the trial or arebreastfeeding

Study Design

Total Participants: 504
Treatment Group(s): 4
Primary Treatment: LEO 90100 aerosol foam
Phase: 3
Study Start date:
June 01, 2014
Estimated Completion Date:
February 28, 2015

Connect with a study center

  • Service de Dermatologie, Hôspital Larrey

    Toulouse, 31059
    France

    Site Not Available

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