Trials Sponsors Conditions Drugs Pricing

Conditions

Plaque Type Psoriasis

Keywords

psoriasis

Outcome Measures

Primary Outcomes (1)

Change from baseline in Local Plaque Severity Index (LPSI)
Measurement of plaque severity including erythema, induration, and desquamation.
Baseline, day 15, day 33

Secondary Outcomes (1)

The number of patients with adverse events
daily to and including Day33

Study Arms (1)

SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate

EXPERIMENTAL

A 100 mg dose of SHP-141C cream at three concentrations (0.5%, 1.0% and 2.0%), a matched placebo cream and two reference treatments: Calcipotriol 0.005% cream and Betamethasone Valerate 0.02% cream, applied topically to a selected plaque on each subject, six times per week over 28 days for a total of 24 doses.

Drug: SHP-141CDrug: Placebo to SHP-141CDrug: Betamethasone ValerateDrug: Calcipotriol

Interventions

SHP-141CDrug

Topical Cream

Also known as: SHAPE

SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate

Placebo to SHP-141CDrug

Placebo Topical Cream

Also known as: Placebo to SHAPE

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Mild to moderate chronic plaque-type psoriasis.
psoriasis of at least one year.

Sponsors & Collaborators

TetraLogic Pharmaceuticals
Industrylead

Study Sites (1)

Nucleus Network Limited

Melbourne, Victoria, 3004, Australia

MeSH Terms

Conditions

Psoriasis

Interventions

Betamethasone Valeratecalcipotriene

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BetamethasonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

Peter Foley
The Alfred
PRINCIPAL INVESTIGATOR

Enrollment

14 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 20, 2012

Study Start

September 2012

Date type not reported

This date has not been verified as actual or estimated.

SHP-141C in Plaque Type Psoriasis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations