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

NCT ID: NCT05488990

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-25
• Study Completion Date: 2013-06-17

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm with several test fields

Altogether six test fields (two active formulations, their corresponding vehicles and two comparators) located on the torso, or the extremities were randomly assigned for treatments per subject.

Group Type: EXPERIMENTAL

AKVANO-Calcipotriol formulation 1

Intervention Type: DRUG

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

AKVANO-Calcipotriol formulation 2

Intervention Type: DRUG

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

AKVANO vehicle formulation 1

Intervention Type: DRUG

Novel lipid based formulation (AKVANO) vehicle 1

AKVANO vehicle formulation 2

Intervention Type: DRUG

Novel lipid based formulation (AKVANO) vehicle 2

Daivonex solution

Intervention Type: DRUG

Daivonex solution containing Calcipotriol (50 μg/g)

Daivonex cream

Intervention Type: DRUG

Daivonex cream containing Calcipotriol (50 μg/g)

Interventions

AKVANO-Calcipotriol formulation 1

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

Intervention Type: DRUG

AKVANO-Calcipotriol formulation 2

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

Intervention Type: DRUG

AKVANO vehicle formulation 1

Novel lipid based formulation (AKVANO) vehicle 1

Intervention Type: DRUG

AKVANO vehicle formulation 2

Novel lipid based formulation (AKVANO) vehicle 2

Intervention Type: DRUG

Daivonex solution

Daivonex solution containing Calcipotriol (50 μg/g)

Intervention Type: DRUG

Daivonex cream

Daivonex cream containing Calcipotriol (50 μg/g)

Intervention Type: DRUG

Other Intervention Names

AKVC01; AKVC02; AKVC01 vehicle; AKVC02 vehicle

Eligibility Criteria

Inclusion Criteria

All of the following criteria had to be met for inclusion of a subject in the clinical trial:

• Subjects with psoriasis vulgaris in a chronic stable phase and mild or moderate plaque(s) with up to three plaque areas sufficient for six treatment fields
• The target lesion(s) should have been on the trunk or extremities (excluding palms/soles); psoriatic lesion on the knees were not used as a target lesion
• Plaques to be treated should have had a comparable psoriatic infiltrate thickness of at least 200 μm
• The physical examination of the skin had to be without disease findings unless the investigator considered an abnormality to be irrelevant to the outcome of the clinical trial
• Female volunteers of childbearing potential had to be either surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices [IUDs], sexual abstinence or had a vasectomized partner
• Written informed consent obtained

Exclusion Criteria

Subjects were excluded from the clinical trial when one or more of the following conditions were met:

• Other skin disease noted on physical examination that was considered by the investigator to be relevant to the outcome of the trial;
• Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis
• Any topical antipsoriatic treatment on the plaques to be treated in this trial (including corticosteroids, except for salicylic acid) in the three months before first treatment and/or during the trial
• Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids in the three months before first treatment and during the trial
• Treatment with systemic or locally acting medications which might have countered or influenced the trial aim (medications which were known to provoke or aggravate psoriasis, e.g. ß-blocker, antimalarial drugs, lithium) within three months before first treatment and/or during the trial
• Known allergic reactions irritations or sensitivity to the active ingredients or other components of the investigational products;
• Contraindications according to summary of product characteristics of Daivonex®
• Evidence of drug or alcohol abuse
• Pregnancy or nursing
• UV-therapy within four weeks before first treatment and during the trial
• Symptoms of a clinically significant illness that might have influenced the outcome of the trial in the four weeks before first treatment and during the trial
• Participation in the treatment phase of another clinical trial within the last four weeks prior to the first treatment in this clinical trial
• In the opinion of the investigator or physician performing the initial examination the subject should not have participated in the clinical trial, e.g. due to probable non-compliance or inability to understand the trial and give adequately informed consent
• Close affiliation with the investigator (e.g. a close relative) or persons working at bioskin GmbH or subject was an employee of sponsor
• Subject was institutionalized because of legal or regulatory order

• Minimum Eligible Age: 32 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioskin GmbH

INDUSTRY

Sponsor Role: collaborator

Lipidor AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heinrich Siemetzki, MD

Role: PRINCIPAL_INVESTIGATOR

Bioskin GmbH

Locations

bioskin GmbH

Bergmannstrasse, State of Berlin, Germany

Countries

Germany

References

Holmback J, Rinwa V, Halthur T, Rinwa P, Carlsson A, Herslof B. AKVANO(R): A Novel Lipid Formulation System for Topical Drug Delivery-In Vitro Studies. Pharmaceutics. 2022 Apr 5;14(4):794. doi: 10.3390/pharmaceutics14040794.

Reference Type: BACKGROUND

PMID: 35456628 (View on PubMed)

Other Identifiers

2012-003951-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CALC01 / 310905BS

Identifier Type: -

Identifier Source: org_study_id