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Clinical Trials/NL-OMON37524
NL-OMON37524
Completed
Phase 4

Optimising outpatient care in mild to moderate psoriasis by a newly developed *Topical Treatment Optimising Programme* - an international study using Daivobet®/Dovobet® Gel (*PSO-TOP*) - PSO-TOP

SCIderm GmbH0 sites70 target enrollmentTBD
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Conditionsplaque psoriasispsoriasis1000381610014982

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
plaque psoriasis
Sponsor
SCIderm GmbH
Enrollment
70
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Trial is onging in other countries

Registry
who.int
Start Date
TBD
End Date
September 8, 2014
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
SCIderm GmbH

Eligibility Criteria

Inclusion Criteria

  • •\- Male and female patients aged at least 18 years
  • •\- Mild to moderate active plaque psoriasis with a PGA \* 2 on the 7 point scale by Langley and Ellis and a Body Surface Area (BSA) of \* 10%
  • •\- Topical psoriasis treatment with coal or tar preparations, tazarotene, steroids, or vitamin D analogues, or combinations of steroids and vitamin D analogues (except gel combination products containing 50 micrograms calcipotriol / 0\.5 mg betamethasone/g) or dithranol and its combination preparations over the last 8 weeks prior to Visit 1 (week 0\)
  • •\- Written informed consent to participate in the study has been given prior to any study related procedures

Exclusion Criteria

  • •\- Severe renal insufficiency
  • •\- Severe hepatic disorders
  • •\- Known hyper calcaemia
  • •\- Erythrodermic, exfoliative, pustular or guttate psoriasis
  • •\- Facial or genital psoriasis
  • •\- Fulfilment of at least one contraindication according to the Summary of Product Characteristics of Daivobet®/Dovobet®
  • •\- Pregnant and/or breast\-feeding women
  • •\- Hypersensitivity to the active substances or to any of the excipients
  • •\- Suspected non\-compliance with the clinical study procedures
  • •\- Current participation in another clinical study

Outcomes

Primary Outcomes

Not specified

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