AzTrials
AzTrials

Psoriasis VulgarisPhase 1/2AKVANO-AKP01NCT05488990

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

A Phase 1/2 study testing AKVANO-Calcipotriol formulation 1, AKVANO-Calcipotriol formulation 2 and Daivonex solution in people with Psoriasis Vulgaris, run by Lipidor AB at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 32 to 69 years
Conditions the study is for
Psoriasis Vulgaris
What is being tested?
AKVANO-Calcipotriol formulation 1, AKVANO-Calcipotriol formulation 2 and Daivonex solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteGermany
Study dates
25 Mar 2013to 17 Jun 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 32 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • bioskin GmbH

    Bergmannstrasse, State of Berlin, 10961

Other trials in Germany

About this study

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

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

Read the 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.

Being tested
AKVANO-Calcipotriol formulation 1, AKVANO-Calcipotriol formulation 2, AKVANO vehicle formulation 1, AKVANO vehicle formulation 2, Daivonex solution
Keywords
psoriasis plaque test, sonographic measurement, psoriatic infiltrate, clinical efficacy assessments, cutaneous safety, calcipotriene, calcipotriol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AKVANO-Calcipotriol formulation 1Drug

    Also called AKVC01

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

  • AKVANO-Calcipotriol formulation 2Drug

    Also called AKVC02

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

  • AKVANO vehicle formulation 1Drug

    Also called AKVC01 vehicle

    Novel lipid based formulation (AKVANO) vehicle 1

  • AKVANO vehicle formulation 2Drug

    Also called AKVC02 vehicle

    Novel lipid based formulation (AKVANO) vehicle 2

  • Daivonex solutionDrug

    Daivonex solution containing Calcipotriol (50 μg/g)

  • Daivonex creamDrug

    Daivonex cream containing Calcipotriol (50 μg/g)

Study groups in NCT05488990
Study groupRoleWhat they receive
Single arm with several test fieldsExperimentalAltogether 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 days

Secondary outcomes (4)

  1. 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

    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.

    Measured: 12 days

  2. 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

    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.

    Measured: 8 days

  3. Clinical assessment of the treatment efficacy of all formulations at day 8

    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).

    Measured: 8 days

  4. Clinical assessment of the treatment efficacy of all formulations at day 12

    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).

    Measured: 12 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start25 Mar 2013
  3. Primary completion17 Jun 2013
  4. Study completion17 Jun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05488990
Sponsor's protocol ID
CALC01 / 310905BS
Other IDs
2012-003951-12
Acronym
AKVANO-AKP01
Status last verified
Aug 2022
First submitted
1 Aug 2022
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35456628

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AKVANO-Calcipotriol formulation 1, AKVANO-Calcipotriol formulation 2 and Daivonex solution in people with Psoriasis Vulgaris, run by Lipidor AB at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05488990, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in