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Trial to Evaluate Topical C-82 in a Psoriasis Plaque Test

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ClinicalTrials.gov Identifier: NCT02432027
Recruitment Status : Completed
First Posted : May 1, 2015
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Prism Pharma Co., Ltd.

Brief Summary:
Evaluate the effects of topical C-82 in a psoriasis plaque test.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: C-82 Topical Gel, Placebo Drug: C-82 Topical Gel, 1% Drug: Daivonex cream Drug: Diprosis gel Phase 1 Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: IMP 1
C-82 Topical Gel, 1%
Drug: C-82 Topical Gel, 1%
active

Placebo Comparator: IMP 2
C-82 Topical Gel, placebo
Drug: C-82 Topical Gel, Placebo
placebo

Active Comparator: IMP 3
Daivonex cream
Drug: Daivonex cream
comparator
Other Name: calcipotriol 50mcg/g

Active Comparator: IMP 4
Diprosis gel
Drug: Diprosis gel
comparator
Other Name: betamethasone, 0.5 mg/g




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. antipsoriatic efficacy compared to control by clinical assessment using a 5-point score. [ Time Frame: Day 8 & Day 12 ]
  2. number of subjects with adverse events [ Time Frame: daily through Day 12 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432027


Locations
Germany
Schwerin, Germany
Sponsors and Collaborators
Prism Pharma Co., Ltd.
Investigators
Principal Investigator: Elisabeth Theis, MD Klinische Forschung Schwerin GmbH

Responsible Party: Prism Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02432027     History of Changes
Other Study ID Numbers: PRI-C-82T-2101
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: October 2015

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Dermatologic Agents