Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2016-11-03
2017-03-24
Brief Summary
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The objective was 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.
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Detailed Description
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* on 2 mini-zones pretreated by a keratolytic product, would be tested:
* CD10367 3% solution
* CD10367 solution placebo
* on 4 mini-zones non-pretreated, would be tested:
* CD10367 3% solution
* CD10367 1% solution
* CD10367 solution placebo
* Betneval 0.1% ointment
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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CD10367 3% Solution - Non-desquamated zone
CD10367 3% Solution - Non-desquamated zone
Once daily application for 3 weeks
CD10367 1% Solution - Non-desquamated zone
CD10367 1% Solution - Non-desquamated zone
Once daily application for 3 weeks
CD10367 solution placebo - Non-desquamated zone
CD10367 solution placebo serves as negative control.
CD10367 solution placebo - Non-desquamated zone
Once daily application for 3 weeks
Betneval ointment - Non-desquamated zone
This comparator containing Betamethasone valerate 0.1% serves as positive control.
Betneval ointment - Non-desquamated zone
Once daily application for 3 weeks
CD10367 3% Solution - Desquamated zone
CD10367 3% Solution - Desquamated zone
Once daily application for 3 weeks
CD10367 solution placebo - Desquamated zone
CD10367 solution placebo - Desquamated zone
Once daily application for 3 weeks
Interventions
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CD10367 3% Solution - Non-desquamated zone
Once daily application for 3 weeks
CD10367 1% Solution - Non-desquamated zone
Once daily application for 3 weeks
CD10367 solution placebo - Non-desquamated zone
Once daily application for 3 weeks
Betneval ointment - Non-desquamated zone
Once daily application for 3 weeks
CD10367 3% Solution - Desquamated zone
Once daily application for 3 weeks
CD10367 solution placebo - Desquamated zone
Once daily application for 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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).
3. Participant had a skin phototype I to IV on Fitzpatrick's scale. (Screening visit).
4. The participant had 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).
5. The participant presented 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,
6. Participant agreed not to wear his/her contact lenses from the Baseline visit till the D19 visit (Screening visit).
Exclusion Criteria
2. The participant had any uncontrolled or serious disease, or any medical or surgical condition, that might either interfere with the interpretation of the clinical trial results, and/or put the participant at significant risk (according to Investigator's judgment) if he/she participated in the clinical trial (e.g. history of on-going gastric or duodenal ulcer, clinically significant lung disease, etc.) (Screening visit).
3. The participant had 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).
4. The participant had known history of adverse drug reaction or hypersensitivity to a product with the same mode of action.
5. The participant had any abnormal clinically significant findings according to the ophthalmologist, at the ophthalmological exam at Screening visit,
6. The participant presented any abnormal laboratory tests judged clinically significant by the investigator (blood samplings and urinalysis done at Screening visit),
7. The participant had QTc interval \>450 millisecond (msec) or any abnormal electrocardiogram (ECG) value considered as clinically significant by the cardiologist (Screening visit).
8. The participant had received, applied or taken some specified treatments within the specified time frame prior to the Baseline visit.
18 Years
70 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Galderma Investigational Site
Nice, , France
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002774-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RD.03.SPR.112075
Identifier Type: -
Identifier Source: org_study_id
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