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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: C-82 Topical Gel, Placebo; Drug: C-82 Topical Gel, 1%; Drug: Daivonex cream; Drug: Diprosis gel

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
• Enrollment (Actual): 14
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Schwerin, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: calcipotriol 50mcg/g
Active Comparator: IMP 4; Diprosis gel	Drug: Diprosis gel; comparator; Other Names: betamethasone, 0.5 mg/g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	day 12

Secondary Outcome Measures

Outcome Measure	Time Frame
antipsoriatic efficacy compared to control by clinical assessment using a 5-point score.	Day 8 & Day 12
number of subjects with adverse events	daily through Day 12

Collaborators and Investigators

• Sponsor: Prism Pharma Co., Ltd.
• Investigators: Principal Investigator: Elisabeth Theis, MD, Klinische Forschung Schwerin GmbH

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimate): May 1, 2015

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Calcipotriene
• Other Study ID Numbers: PRI-C-82T-2101