Safety and Efficacy of CD10367 in Psoriasis Vulgaris

Study Overview
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Brief Summary
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This is an exploratory, single-centre, investigator blinded, randomized, controlled, intra-individual study, involving subjects with psoriasis vulgaris. The objective is to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once daily application.

Detailed Description
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Study drugs will be applied in each subject once daily, 5 days a week during the first 2 weeks and for 4 days the third week on 6 mini-zones located on at least 2 psoriatic plaques as described below: on 2 mini-zones pretreated by a keratolytic product, will be tested: CD10367 3% solution CD10367 solution placebo on 4 mini-zones non-pretreated, will be tested: CD10367 3% solution CD10367 1% solution CD10367 solution placebo Betneval 0.1% ointment

Official Title
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Exploratory Study to Evaluate the Safety and Efficacy of CD10367 in Subjects With Psoriasis

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: CD10367 3% Solution - Non-desquamated zone
* Drug: CD10367 1% Solution - Non-desquamated zone
* Drug: CD10367 solution placebo - Non-desquamated zone
* Drug: Betneval ointment - Non-desquamated zone
* Drug: CD10367 3% Solution - Desquamated zone
* Drug: CD10367 solution placebo - Desquamated zone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female aged at least 18 and up to 70 years old inclusive at screening visit. Female of non childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], hysterectomy or bilateral oophorectomy). Subject has a skin phototype I to IV on Fitzpatrick's scale. (Screening visit). The subject has a clinical diagnosis of stable plaque psoriasis, defined as no flare during the month before Screening visit and no change between Screening visit and Baseline visit, of mild to moderate severity. (Screening visit and Baseline Visit). The subject presents with at least six eligible mini-zones, on at least two psoriasis plaques (Screening visit and verified also at Baseline Visit) with specific severity grades, Subject agrees not to wear his/her contact lenses from the Baseline visit till the D19 visit, (Screening visit) Exclusion Criteria: The subject presents guttate, erythrodermic, exfoliative, inverse, pustular, palmo plantar, infected or ulcerated psoriasis (Screening visit). The subject has any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial (e.g. history of on-going gastric or duodenal ulcer, clinically significant lung disease, etc.) (Screening visit). The subject has known or suspected allergies or sensitivities to any components of the study drugs or of the keratolytic product (see Investigator's Brochure/Product label). (Screening visit). The subject has known history of adverse drug reaction or hypersensitivity to a product with the same mode of action The subject has any abnormal clinically significant findings according to the ophthalmologist, at the ophthalmological exam at Screening visit, The subject presents any abnormal laboratory tests judged clinically significant by the investigator (blood samplings and urinalysis done at Screening visit), The subject has QTc interval >450msec or any abnormal ECG value considered as clinically significant by the cardiologist (Screening visit). The subject has received, applied or taken some specified treatments within the specified time frame prior to the Baseline visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD10367 3% Solution - Non-desquamated zone<br> | Drug: CD10367 3% Solution - Non-desquamated zone<br>* Once daily application for 3 weeks<br>|
| Experimental: CD10367 1% Solution - Non-desquamated zone<br> | Drug: CD10367 1% Solution - Non-desquamated zone<br>* Once daily application for 3 weeks<br>|
| Placebo Comparator: CD10367 solution placebo - Non-desquamated zone<br>CD10367 solution placebo serves as negative control. | Drug: CD10367 solution placebo - Non-desquamated zone<br>* Once daily application for 3 weeks<br>|
| Active Comparator: Betneval ointment - Non-desquamated zone<br>This comparator containing Betamethasone valerate 0.1% serves as positive control. | Drug: Betneval ointment - Non-desquamated zone<br>* Once daily application for 3 weeks<br>* Other names: Betamethasone Valerate;|
| Experimental: CD10367 3% Solution - Desquamated zone<br> | Drug: CD10367 3% Solution - Desquamated zone<br>* Once daily application for 3 weeks<br>|
| Placebo Comparator: CD10367 solution placebo - Desquamated zone<br> | Drug: CD10367 solution placebo - Desquamated zone<br>* Once daily application for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC) of Total Sum Score (sum of erythema, scaling and induration scores) from Baseline to Day 19 | Investigator's rating of the clinical appearance of each psoriatic mini-zone. The single items erythema, scaling, and induration (maximum score 4 each) are summed to obtain the Total Sum Score. Maximum score is 12 (very severe); minimum score is 0 (None). | Baseline to Day 19 |