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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432027
• Other study ID #: PRI-C-82T-2101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 28, 2015
• Last updated: August 16, 2017
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Prism Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prism Pharma Co., Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	antipsoriatic efficacy compared to control by clinical assessment using a 5-point score.		Day 8 & Day 12
Secondary	number of subjects with adverse events		daily through Day 12