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

NCT ID: NCT02432027

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-09-30

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IMP 1

C-82 Topical Gel, 1%

Group Type: EXPERIMENTAL

C-82 Topical Gel, 1%

Intervention Type: DRUG

active

IMP 2

C-82 Topical Gel, placebo

Group Type: PLACEBO_COMPARATOR

C-82 Topical Gel, Placebo

Intervention Type: DRUG

placebo

IMP 3

Daivonex cream

Group Type: ACTIVE_COMPARATOR

Daivonex cream

Intervention Type: DRUG

comparator

IMP 4

Diprosis gel

Group Type: ACTIVE_COMPARATOR

Diprosis gel

Intervention Type: DRUG

comparator

Interventions

C-82 Topical Gel, Placebo

placebo

Intervention Type: DRUG

C-82 Topical Gel, 1%

active

Intervention Type: DRUG

Daivonex cream

comparator

Intervention Type: DRUG

Diprosis gel

comparator

Intervention Type: DRUG

Other Intervention Names

calcipotriol 50mcg/g; betamethasone, 0.5 mg/g

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Prism Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth Theis, MD

Role: PRINCIPAL_INVESTIGATOR

Klinische Forschung Schwerin GmbH

Locations

Schwerin, , Germany

Countries

Germany

Other Identifiers

PRI-C-82T-2101

Identifier Type: -

Identifier Source: org_study_id