A Phase 1/2 interventional study of AKVANO-Calcipotriol formulation 1 and AKVANO-Calcipotriol formulation 2 in Psoriasis Vulgaris, sponsored by Lipidor AB. Completed at 1 site in Germany. Open to participants aged 32 Years to 69 Years. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by Lipidor AB · Phase 1/2, Interventional, and Treatment
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
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 24 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Lipidor AB is the lead sponsor of 2 studies on the registry; none are open to participants now.
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All of the following criteria had to be met for inclusion of a subject in the clinical trial:
Exclusion Criteria:
Subjects were excluded from the clinical trial when one or more of the following conditions were met:
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
Novel lipid based formulation (AKVANO) type 1 containing Calcipotriol (50 μg/g)
Also known as: AKVC01
Novel lipid based formulation (AKVANO) type 2 containing Calcipotriol (50 μg/g)
Also known as: AKVC02
Novel lipid based formulation (AKVANO) vehicle 1
Also known as: AKVC01 vehicle
Novel lipid based formulation (AKVANO) vehicle 2
Also known as: AKVC02 vehicle
Daivonex solution containing Calcipotriol (50 μg/g)
Daivonex cream containing Calcipotriol (50 μg/g)
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.
Time frame: 12 days
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.
Time frame: 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
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.
Time frame: 8 days
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).
Time frame: 8 days
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).
Time frame: 12 days
All Adverse events (AEs) (non-treatment-emergent and treatment-emergent) will be documented.
All Adverse events (AEs) (non-treatment-emergent and treatment-emergent) will be documented.
Time frame: 12 days
Plan to share: No
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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