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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518048
Recruitment Status : Completed
First Posted : August 7, 2015
Results First Posted : April 21, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease Intervention/treatment Phase
Skin and Connective Tissue Diseases Drug: LEO 90100 Aerosol foam Drug: Betesil® 2.25 mg Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 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 LEO 90100 Aerosol Foam Compared to Betesil® Medicated Plaster in the Treatment of Psoriasis Vulgaris
Study Start Date : August 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: LEO 90100 Aerosol foam
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
Drug: LEO 90100 Aerosol foam
Active Comparator: Betesil® 2.25 mg
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® )
Drug: Betesil® 2.25 mg



Primary Outcome Measures :
  1. Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, Infiltration) Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, and Infiltration) at End of Treatment Compared to Baseline [ Time Frame: Day 1 (Baseline) to Day 29 ]

    The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe).

    The total TCS was calculated for each test site by summing the scores for erythema, scaling, and infiltration for that particular test site.

    Each test site was assessed at Baseline and on Days 4, 8, 11, 15, 18, 22, 25, and 29 (EoT).

    The mean TCS at Baseline was 6.6 for both groups.



Secondary Outcome Measures :
  1. Change in TCS at Individual Visits [ Time Frame: Day 1 (Baseline) to Day 29 ]
  2. Change in Score of Erythema, Scaling, and Infiltration at Individual Visits [ Time Frame: Day 1 (Baseline) to Day 29 ]

    The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe).

    Erythema: 0 (no evidence - normal skin color) to 3 (severe - intense red). Scaling: 0 (no evidence - no scaling) to 3 (severe - coarse, thick scales). Infiltration: 0 (no evidence - no infiltration) to 3 (severe - very marked infiltration).


  3. Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT [ Time Frame: Baseline to End of Treatment ]

    Skin thickness ultrasound measurements of the test sites were performed at Baseline and End of Treatment.

    Two skin parameters were calculated using ultrasound:

    • The mean total skin thickness
    • The mean echo-poor band thickness



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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 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

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): NCT02518048


Locations
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France
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Nice, France, 06000
Sponsors and Collaborators
LEO Pharma
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02518048    
Other Study ID Numbers: LP0053-1227
First Posted: August 7, 2015    Key Record Dates
Results First Posted: April 21, 2017
Last Update Posted: June 1, 2017
Last Verified: May 2017
Keywords provided by LEO Pharma:
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Connective Tissue Diseases
Skin Diseases, Papulosquamous
Skin Diseases