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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

C-82 Topical Gel, Placebo

C-82 Topical Gel, 1%

Daivonex cream

Diprosis gel

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

IMP 1

IMP 2

IMP 3

IMP 4

Arm Description

C-82 Topical Gel, 1%

C-82 Topical Gel, placebo

Daivonex cream

Diprosis gel

Outcomes

Primary Outcome 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

Secondary Outcome Measures

antipsoriatic efficacy compared to control by clinical assessment using a 5-point score.

number of subjects with adverse events

Full Information

NCT ID

NCT02432027

First Posted

April 28, 2015

Last Updated

August 16, 2017

Sponsor

Prism Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02432027

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Prism Pharma Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IMP 1

Arm Type

Experimental

Arm Description

C-82 Topical Gel, 1%

Arm Title

IMP 2

Arm Type

Placebo Comparator

Arm Description

C-82 Topical Gel, placebo

Arm Title

IMP 3

Arm Type

Active Comparator

Arm Description

Daivonex cream

Arm Title

IMP 4

Arm Type

Active Comparator

Arm Description

Diprosis gel

Intervention Type

Drug

Intervention Name(s)

C-82 Topical Gel, Placebo

Intervention Description

placebo

Intervention Type

Drug

Intervention Name(s)

C-82 Topical Gel, 1%

Intervention Description

active

Intervention Type

Drug

Intervention Name(s)

Daivonex cream

Other Intervention Name(s)

calcipotriol 50mcg/g

Intervention Description

comparator

Intervention Type

Drug

Intervention Name(s)

Diprosis gel

Other Intervention Name(s)

betamethasone, 0.5 mg/g

Intervention Description

comparator

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

antipsoriatic efficacy compared to control by clinical assessment using a 5-point score.

Time Frame

Day 8 & Day 12

Title

number of subjects with adverse events

Time Frame

daily through Day 12

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elisabeth Theis, MD

Organizational Affiliation

Klinische Forschung Schwerin GmbH

Official's Role

Principal Investigator

Facility Information:

City

Schwerin

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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