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A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123) (LP0113-1123)

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ClinicalTrials.gov Identifier: NCT02416258
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.

Condition or disease Intervention/treatment Phase
Skin and Connective Tissue Diseases Drug: LP0113 aerosol spray Drug: Aerosol spray vehicle Drug: LEO 90100 aerosol foam Drug: Betamethasone dipropionate aerosol spray Drug: Calcipotriol aerosol spray Drug: Daivobet® gel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LP0113 Aerosol Spray Compared With Its Vehicle and With Daivobet® Gel, LEO 90100 Aerosol Foam, Betamethasone Dipropionate Aerosol Spray and Calcipotriol Aerosol Spray in the Treatment of Psoriasis Vulgaris
Study Start Date : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: LP0113 aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
Drug: Aerosol spray vehicle
Drug: LEO 90100 aerosol foam
Drug: Betamethasone dipropionate aerosol spray
Drug: Calcipotriol aerosol spray
Drug: Daivobet® gel
Placebo Comparator: Aerosol spray vehicle
No active ingredient, topical
Drug: LP0113 aerosol spray
Drug: LEO 90100 aerosol foam
Drug: Betamethasone dipropionate aerosol spray
Drug: Calcipotriol aerosol spray
Drug: Daivobet® gel
Active Comparator: LEO 90100 aerosol foam
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
Drug: LP0113 aerosol spray
Drug: Aerosol spray vehicle
Drug: Betamethasone dipropionate aerosol spray
Drug: Calcipotriol aerosol spray
Drug: Daivobet® gel
Active Comparator: Betamethasone dipropionate aerosol spray
Betamethasone (as dipropionate) 0.5 mg/g, topical
Drug: LP0113 aerosol spray
Drug: Aerosol spray vehicle
Drug: LEO 90100 aerosol foam
Drug: Calcipotriol aerosol spray
Drug: Daivobet® gel
Active Comparator: Calcipotriol aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g, topical
Drug: LP0113 aerosol spray
Drug: Aerosol spray vehicle
Drug: LEO 90100 aerosol foam
Drug: Betamethasone dipropionate aerosol spray
Drug: Daivobet® gel
Active Comparator: Daivobet® gel
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
Drug: LP0113 aerosol spray
Drug: Aerosol spray vehicle
Drug: LEO 90100 aerosol foam
Drug: Betamethasone dipropionate aerosol spray
Drug: Calcipotriol aerosol spray



Primary Outcome Measures :
  1. Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration) [ Time Frame: End of treatment compared to baseline - 4 weeks ]

Secondary Outcome Measures :
  1. Absolute change in single clinical sign score: erythema, scaling, infiltration [ Time Frame: End of treatment and individual visits compared to baseline - 4 weeks ]
  2. Absolute Change in Total Clinical Score (TCS) [ Time Frame: Individual visits compared to baseline - 4 weeks ]
  3. Absolute change in total skin thickness and echo-poor band thickness [ Time Frame: End of treatment compared to baseline - 4 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent has been obtained
  • Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416258


Locations
France
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Nice, France, 06000
Sponsors and Collaborators
LEO Pharma

Additional Information:
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02416258     History of Changes
Other Study ID Numbers: LP0113-1123
2014-004759-30 ( EudraCT Number )
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by LEO Pharma:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Connective Tissue Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents