A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123)
LP0113-1123
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
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 9, 2015
CompletedFirst Posted
Study publicly available on registry
April 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFebruary 24, 2025
May 1, 2017
2 months
April 9, 2015
February 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)
End of treatment compared to baseline - 4 weeks
Secondary Outcomes (3)
Absolute change in single clinical sign score: erythema, scaling, infiltration
End of treatment and individual visits compared to baseline - 4 weeks
Absolute Change in Total Clinical Score (TCS)
Individual visits compared to baseline - 4 weeks
Absolute change in total skin thickness and echo-poor band thickness
End of treatment compared to baseline - 4 weeks
Study Arms (6)
LP0113 aerosol spray
ACTIVE COMPARATORCalcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
Aerosol spray vehicle
PLACEBO COMPARATORNo active ingredient, topical
LEO 90100 aerosol foam
ACTIVE COMPARATORCalcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
Betamethasone dipropionate aerosol spray
ACTIVE COMPARATORBetamethasone (as dipropionate) 0.5 mg/g, topical
Calcipotriol aerosol spray
ACTIVE COMPARATORCalcipotriol (as monohydrate) 50 mcg/g, topical
Daivobet® gel
ACTIVE COMPARATORCalcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (1)
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Nice, 06000, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2015
First Posted
April 14, 2015
Study Start
April 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
February 24, 2025
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share