Schwerin, Germany
NCT Number: NCT02432027
Trial to Evaluate Topical C-82 in a Psoriasis Plaque Test
Evaluate the effects of topical C-82 in a psoriasis plaque test.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
About this study
The primary objective of this trial is to evaluate antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate using 20 MHz sonography. To gain additional information about possible efficacy the change of the test fields compared to untreated plaque will be clinically assessed by visual scoring.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- mild to moderate chronic stable plaque type psoriasis
- plaques thickness of at least 200 µm
- lesion(s) on the trunk or extremities (excluding palms/soles)
- skin must be without disease findings
Exclusion criteria
- other skin disease
- psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis
- treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) within 2 weeks preceding and during the trial
- treatment with any systemic medications (including anti-psoriatics like corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (e.g. beta-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding and during the trial
- treatment with any biologics within 3 months preceding and during the trial
- known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products (e.g. Carbomere 940, propylene glycol)
- drug or alcohol abuse
- symptoms of a clinically significant illness within 4 preceding and during the trial
- participation another clinical trial within 4 weeks of this clinical trial
Treatment and study plan
C-82 Topical Gel, Placebo
Drugplacebo
C-82 Topical Gel, 1%
Drugactive
Daivonex cream
Drugcomparator
Other names: calcipotriol 50mcg/g
Diprosis gel
Drugcomparator
Other names: betamethasone, 0.5 mg/g
Primary outcomes
-
antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate
Time frame: day 12
Secondary outcomes
-
antipsoriatic efficacy compared to control by clinical assessment using a 5-point score.
Time frame: Day 8 & Day 12
-
number of subjects with adverse events
Time frame: daily through Day 12
Sponsors and collaborators
Lead sponsor
Prism Pharma Co., Ltd.
Industry
Registry information
Official study title
A Single-Center, Randomized, Observer Blind, Vehicle- and Comparator-controlled Trial to Evaluate the Antipsoriatic Efficacy and Safety of Topical Formulations of C-82 in a Psoriasis Plaque Test
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- May 1, 2015
- Registry last updated
- Aug 17, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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