LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris

NCT01866163 | Completed Phase 3 Results

• 1 other identifier: LP0053-1001
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Treatment Success According to IGA

  Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4. The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe

  4 weeks

Secondary Outcomes (2)

• m-PASI at Week 4

  4 weeks

• m-PASI at Week 1

  1 week

Study Arms (2)

LEO 90100

EXPERIMENTAL

LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)

Drug: LEO 90100

Vehicle

PLACEBO COMPARATOR

Aerosol foam vehicle

Drug: Vehicle

Interventions

LEO 90100 DRUG

LEO 90100

Vehicle DRUG

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs
• Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA)
• An Investigator's Global Assessment of disease severity (IGA) of at least mild at Day 0 (Visit 1)
• A modified PASI (m-PASI) score of at least 2 at Day 0 (Visit 1)
• A target lesion of a minimum of 5 cm at its longest axis and preferably not located on the extensor surface on an elbow or knee, scoring at least 1 for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion

You may not qualify if:

• 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, 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 (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.
• 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 D analogues or prescription shampoos within 2 weeks prior to randomisation.
• Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the trial.
• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
• Previously randomised in this trial or any previously conducted trial of LEO 90100.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Central Dermatology

St Louis, Missouri, 63117, United States

Location

Related Publications (4)

• Veverka KA, Hansen JB, Yaloumis M, Kircik L, Stein Gold L. Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials. J Drugs Dermatol. 2021 Aug 1;20(8):822-828. doi: 10.36849/JDD.5743.

  PMID: 34397196 DERIVED

• Iversen L, Kurvits M, Snel-Prento AM, Menter A. Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5-15% and PGA >/= 3: Post-Hoc Analysis From Three Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Oct;10(5):1111-1120. doi: 10.1007/s13555-020-00419-2. Epub 2020 Aug 12.

  PMID: 32785881 DERIVED

• Stein Gold L, Villumsen J, Rosen M. Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam is Effective, Independent of Body Mass Index and the Extent and Severity of Psoriasis. Dermatol Ther (Heidelb). 2016 Dec;6(4):667-673. doi: 10.1007/s13555-016-0147-0. Epub 2016 Oct 6.

  PMID: 27714595 DERIVED

• Leonardi C, Bagel J, Yamauchi P, Pariser D, Xu Z, Olesen M, Osterdal ML, Stein Gold L. Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST). J Drugs Dermatol. 2015 Dec;14(12):1468-77.

  PMID: 26659941 DERIVED

Related Links

• Clinical Trials at LEO Pharma

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

ctr.disclosure@leo-pharma.com

+45 44945888

Study Officials

• Craig Leonardi

  Central Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 31, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 10, 2025
• Results First Posted: May 9, 2016

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)