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Efficacy and Safety of Novel Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis

NCT05488990 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-08-05

No results posted yet for this study

Summary

This was a Phase I, single-center, randomized, controlled trial to evaluate the antipsoriatic efficacy of calcipotriol in novel formulations based on AKVANO technology as compared to marketed calcipotriol products (Daivonex® solution and cream) and to evaluate their cutaneous safety in a psoriasis plaque test

Conditions

  • Psoriasis Vulgaris

Interventions

DRUG

AKVANO-Calcipotriol formulation 1

Novel lipid based formulation (AKVANO) type 1 containing Calcipotriol (50 μg/g)

DRUG

AKVANO-Calcipotriol formulation 2

Novel lipid based formulation (AKVANO) type 2 containing Calcipotriol (50 μg/g)

DRUG

AKVANO vehicle formulation 1

Novel lipid based formulation (AKVANO) vehicle 1

DRUG

AKVANO vehicle formulation 2

Novel lipid based formulation (AKVANO) vehicle 2

DRUG

Daivonex solution

Daivonex solution containing Calcipotriol (50 μg/g)

DRUG

Daivonex cream

Daivonex cream containing Calcipotriol (50 μg/g)

Sponsors & Collaborators

  • Bioskin GmbH

    collaborator INDUSTRY

  • Lipidor AB

    lead INDUSTRY

Principal Investigators

  • Heinrich Siemetzki, MD · Bioskin GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
32 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-25
Primary Completion
2013-06-17
Completion
2013-06-17

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05488990 on ClinicalTrials.gov