Back to resultsA Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris
Primary Purpose
Skin and Connective Tissue Diseases
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
LEO 90100 Aerosol foam
Betesil® 2.25 mg
Sponsored by
About this trial
This is an interventional treatment trial for Skin and Connective Tissue Diseases focused on measuring Psoriasis
Eligibility 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
Sites / Locations
- Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LEO 90100 Aerosol foam
Betesil® 2.25 mg
Arm Description
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
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® )
Outcomes
Primary Outcome Measures
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
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
Change in TCS at Individual Visits
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
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).
Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02518048
Brief Title
A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Connective Tissue Diseases
Keywords
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 90100 Aerosol foam
Arm Type
Active Comparator
Arm Description
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
Arm Title
Betesil® 2.25 mg
Arm Type
Active Comparator
Arm 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® )
Intervention Type
Drug
Intervention Name(s)
LEO 90100 Aerosol foam
Intervention Type
Drug
Intervention Name(s)
Betesil® 2.25 mg
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 1 (Baseline) to Day 29
Secondary Outcome Measure Information:
Title
Change in TCS at Individual Visits
Time Frame
Day 1 (Baseline) to Day 29
Title
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Description
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).
Time Frame
Day 1 (Baseline) to Day 29
Title
Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT
Description
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
Time Frame
Baseline to End of Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27995521
Citation
Queille-Roussel C, Rosen M, Clonier F, Norremark K, Lacour JP. Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam Compared with Betamethasone 17-Valerate-Medicated Plaster for the Treatment of Psoriasis. Clin Drug Investig. 2017 Apr;37(4):355-361. doi: 10.1007/s40261-016-0489-5.
Results Reference
derived
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A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris
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