NCT05488990

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

Phase I, Single-center, Randomized, Controlled Trial to Evaluate the Antipsoriatic Efficacy of Calcipotriol in Novel Formulations Compared to Marketed Calcipotriol Products and Evaluation of Their Cutaneous Safety in a Psoriasis Plaque Test

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Lipidor AB · Industry
• Sex: All
• Age: 32 Years – 69 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study was conducted to evaluate the efficacy and cutaneous safety of calcipotriol (50 μg/g) in novel formulations (AKVANO®) as compared to their corresponding vehicle formulations and marketed calcipotriol formulations (Daivonex®) in a psoriasis plaque test. In total, 24 subjects with chronic psoriasis vulgaris were enrolled in this single-centre, randomized, vehicle and comparator-controlled clinical trial and were treated under occlusion over a 12-day treatment period (10 applications). The anti-psoriatic effect was evaluated by sonographic measurement of the psoriatic infiltrate and investigators' clinical efficacy assessments.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2013-03-25
• Primary completion: 2013-06-17
• Completion: 2013-06-17
• First posted: 2022-08-05
• Last updated: 2022-08-05

Locations

1 site across 1 country: Germany