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

NCT05488990 | Completed Phase 1

• 2 other identifiers: CALC01 / 310905BS2012-003951-12
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Psoriasis Vulgaris

Keywords

psoriasis plaque test; sonographic measurement; psoriatic infiltrate; clinical efficacy assessments; cutaneous safety; calcipotriene; calcipotriol

Outcome Measures

Primary Outcomes (1)

• Comparison of AKVANO-Calcipotriol formulations to their corresponding vehicles in terms of change in infiltrate thickness from baseline to Day 12

  The thickness of psoriatic infiltrate will be recorded as echo lucent psoriatic band (ELB) using a 20 MHz high frequency sonograph (PROFI USB, Taberna pro Medicum, Lueneburg) on day 1 (baseline) and day 12 (end of treatment; EoT). Mean change of infiltrate thickness will be determined.

  12 days

Secondary Outcomes (4)

• Comparison of AKVANO-Calcipotriol formulations to their corresponding comparators (Daivonex solution and cream) in terms of change in infiltrate thickness from baseline to Day 12

  12 days

• Comparison of AKVANO-Calcipotriol formulations to their corresponding vehicles and comparators in terms of change in infiltrate thickness and Area under curve (AUC) of change in infiltrate thickness from baseline to Day 8

  8 days

• Clinical assessment of the treatment efficacy of all formulations at day 8

  8 days

• Clinical assessment of the treatment efficacy of all formulations at day 12

  12 days

Other Outcomes (1)

• All Adverse events (AEs) (non-treatment-emergent and treatment-emergent) will be documented.

  12 days

Study Arms (1)

Single arm with several test fields

EXPERIMENTAL

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.

Drug: AKVANO-Calcipotriol formulation 1; Drug: AKVANO-Calcipotriol formulation 2; Drug: AKVANO vehicle formulation 1; Drug: AKVANO vehicle formulation 2; Drug: Daivonex solution; Drug: Daivonex cream

Interventions

AKVANO-Calcipotriol formulation 1 DRUG

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

Also known as: AKVC01

Single arm with several test fields

AKVANO-Calcipotriol formulation 2 DRUG

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

Also known as: AKVC02

Single arm with several test fields

AKVANO vehicle formulation 1 DRUG

Novel lipid based formulation (AKVANO) vehicle 1

Also known as: AKVC01 vehicle

Single arm with several test fields

AKVANO vehicle formulation 2 DRUG

Novel lipid based formulation (AKVANO) vehicle 2

Also known as: AKVC02 vehicle

Single arm with several test fields

Daivonex solution DRUG

Daivonex solution containing Calcipotriol (50 μg/g)

Single arm with several test fields

Daivonex cream DRUG

Daivonex cream containing Calcipotriol (50 μg/g)

Single arm with several test fields

Eligibility Criteria

• Age: 32 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lipidor AB: lead
• Bioskin GmbH: collaborator

Study Sites (1)

bioskin GmbH

Bergmannstrasse, State of Berlin, 10961, Germany

Location

Related Publications (1)

• 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.

  PMID: 35456628 BACKGROUND

Study Officials

• Heinrich Siemetzki, MD

  Bioskin GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 5, 2022
• Study Start: March 25, 2013
• Primary Completion: June 17, 2013
• Study Completion: June 17, 2013
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)