- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05488990
Efficacy and Safety of Novel Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis (AKVANO-AKP01)
August 3, 2022 updated by: Lipidor AB
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
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
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Berlin
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Bergmannstrasse 5, Berlin, Germany, 10961
- Bioskin GmbH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
32 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Novel lipid based formulation (AKVANO) type 1 containing Calcipotriol (50 μg/g)
Other Names:
Novel lipid based formulation (AKVANO) type 2 containing Calcipotriol (50 μg/g)
Other Names:
Novel lipid based formulation (AKVANO) vehicle 1
Other Names:
Novel lipid based formulation (AKVANO) vehicle 2
Other Names:
Daivonex solution containing Calcipotriol (50 μg/g)
Daivonex cream containing Calcipotriol (50 μg/g)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of AKVANO-Calcipotriol formulations to their corresponding vehicles in terms of change in infiltrate thickness from baseline to Day 12
Time Frame: 12 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 12 days
|
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
|
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
Time Frame: 8 days
|
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 8. Mean change of infiltrate thickness and AUC of infiltrate thickness will be determined.
|
8 days
|
Clinical assessment of the treatment efficacy of all formulations at day 8
Time Frame: 8 days
|
Clinical assessment (global assessment) of the test fields will be made at visit (day 8 and 12) after day 1 using a defined five-point scale of worsened (-1), unchanged (0), slight improvement (1), clear improvement but not completely healed (2) and completely healed (3).
The comparison of single test fields will be made to the untreated plaque(s) beneath the hydrocolloid dressing and next to the respective test field.
Clinically apparent differences in erythema and infiltration will contribute to this global assessment.
At baseline (Day 1) the score will be documented as "0" (unchanged).
|
8 days
|
Clinical assessment of the treatment efficacy of all formulations at day 12
Time Frame: 12 days
|
Clinical assessment (global assessment) of the test fields will be made at visit (day 8 and 12) after day 1 using a defined five-point scale of worsened (-1), unchanged (0), slight improvement (1), clear improvement but not completely healed (2) and completely healed (3).
The comparison of single test fields will be made to the untreated plaque(s) beneath the hydrocolloid dressing and next to the respective test field.
Clinically apparent differences in erythema and infiltration will contribute to this global assessment.
At baseline (Day 1) the score will be documented as "0" (unchanged).
|
12 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All Adverse events (AEs) (non-treatment-emergent and treatment-emergent) will be documented.
Time Frame: 12 days
|
All Adverse events (AEs) (non-treatment-emergent and treatment-emergent) will be documented.
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12 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Heinrich Siemetzki, MD, Bioskin GmbH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2013
Primary Completion (Actual)
June 17, 2013
Study Completion (Actual)
June 17, 2013
Study Registration Dates
First Submitted
August 1, 2022
First Submitted That Met QC Criteria
August 3, 2022
First Posted (Actual)
August 5, 2022
Study Record Updates
Last Update Posted (Actual)
August 5, 2022
Last Update Submitted That Met QC Criteria
August 3, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Dermatologic Agents
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Calcipotriene
- Calcitriol
Other Study ID Numbers
- CALC01 / 310905BS
- 2012-003951-12 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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