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

NCT02432027 | Completed Phase 1

• 1 other identifier: PRI-C-82T-2101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (4)

IMP 1

EXPERIMENTAL

C-82 Topical Gel, 1%

Drug: C-82 Topical Gel, 1%

IMP 2

PLACEBO COMPARATOR

C-82 Topical Gel, placebo

Drug: C-82 Topical Gel, Placebo

IMP 3

ACTIVE COMPARATOR

Daivonex cream

Drug: Daivonex cream

IMP 4

ACTIVE COMPARATOR

Diprosis gel

Drug: Diprosis gel

Interventions

C-82 Topical Gel, Placebo DRUG

placebo

IMP 2

C-82 Topical Gel, 1% DRUG

active

IMP 1

Daivonex cream DRUG

comparator

Also known as: calcipotriol 50mcg/g

IMP 3

Diprosis gel DRUG

comparator

Also known as: betamethasone, 0.5 mg/g

IMP 4

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prism Pharma Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Schwerin, Germany

Location

MeSH Terms

Conditions

Psoriasis

Interventions

calcipotriene; Betamethasone

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Elisabeth Theis, MD

  Klinische Forschung Schwerin GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 17, 2017

Record last verified: 2015-10

Locations

DE (1)