Clinical trial NCT05488990: Efficacy and Safety of Novel Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psoriasis Vulgaris
Keywords: psoriasis plaque test
sonographic measurement
psoriatic infiltrate
clinical efficacy assessments
cutaneous safety
calcipotriene
calcipotriol
Lead sponsor: Lipidor AB
Sponsor class: INDUSTRY
Collaborators: name: Bioskin GmbH
First posted: 2022-08-05
Enrollment: 24
Sex: ALL
Minimum age (years): 32
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Comparison of AKVANO-Calcipotriol formulations to their corresponding vehicles in terms of change in infiltrate thickness from baseline to Day 12
timeFrame: 12 days
Secondary outcomes:
measure: 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
timeFrame: 12 days
measure: 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
timeFrame: 8 days
measure: Clinical assessment of the treatment efficacy of all formulations at day 8
timeFrame: 8 days
measure: Clinical assessment of the treatment efficacy of all formulations at day 12
timeFrame: 12 days
Other outcomes:
measure: All Adverse events (AEs) (non-treatment-emergent and treatment-emergent) will be documented.
timeFrame: 12 days
Locations:
city: Bergmannstrasse 5
country: Germany
facility: bioskin GmbH
state: Berlin
Study officials:
affiliation: Bioskin GmbH
name: Heinrich Siemetzki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.