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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2015

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.

Interventions

  • Drug: C-82 Topical Gel, Placebo
    • placebo
  • Drug: C-82 Topical Gel, 1%
    • active
  • Drug: Daivonex cream
    • comparator
  • Drug: Diprosis gel
    • comparator

Arms, Groups and Cohorts

  • Experimental: IMP 1
    • C-82 Topical Gel, 1%
  • Placebo Comparator: IMP 2
    • C-82 Topical Gel, placebo
  • Active Comparator: IMP 3
    • Daivonex cream
  • Active Comparator: IMP 4
    • Diprosis gel

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • mild to moderate chronic stable plaque type psoriasis
  • plaques thickness of at least 200 ┬Ám
  • 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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Prism Pharma Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elisabeth Theis, MD, Principal Investigator, Klinische Forschung Schwerin GmbH

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