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Doppelblinde, randomisierte, kontrollierte, klinisch-experimentelle Studie der Phase II zum Nachweis der Wirksamkeit mittels Vasokonstriktionstest von Polcortolon® N Spray gegenüber Volonimat® Salbe N und zum Nachweis der Hautverträglichkeit im Patch-Test des Vehikels von Polcortolon® N Spray Double blind, randomized, controlled, clinical-experimental trial (phase 2) to evaluate the efficacy of Polcortolon® N Spray compared to Volominat® Salbe N (ointment) using the vasoconstriction assay and to evaluate skin tolerability of Polcortolon® N Spray and its vehicle using patch test assay - POVO-2009

Doppelblinde, randomisierte, kontrollierte, klinisch-experimentelle Studie der Phase II zum Nachweis der Wirksamkeit mittels Vasokonstriktionstest von Polcortolon® N Spray gegenüber Volonimat® Salbe N und zum Nachweis der Hautverträglichkeit im Patch-Test des Vehikels von Polcortolon® N Spray Double blind, randomized, controlled, clinical-experimental trial (phase 2) to evaluate the efficacy of Polcortolon® N Spray compared to Volominat® Salbe N (ointment) using the vasoconstriction assay and to evaluate skin tolerability of Polcortolon® N Spray and its vehicle using patch test assay - POVO-2009

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-015642-35-DE
Enrollment
Unknown
Registered
2009-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers.

Interventions

Trade Name: Polcortolon® N Spray Pharmaceutical Form: Cutaneous spray* INN or Proposed INN: Triamcinolonacetonid CAS Number: 76-25-5 Concentration unit: g gram(s) Concentration type: equal Concentrati

Sponsors

medphano Arzneimittel GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Signed and understood consent of the volunteers, Signed data protection agreement men or women(1:1), between18 - 65 years generally healthy volunteers with healthy skin. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: History of medikation or drug abuse, severe disease, skin disease in the test area, topical treatment in the testarea, systemic medikation with influence onto the skin, last participation in a clinical trial in the last six months, parallel participation in another clinical trial, lack of understanding or lack of ability to consent, lack of signed consent or data protection agreement, known allergy against Triamcinolonacetonid, clobetaol-17-propionat, Sodium dodecylsulfate or other components of the spray or the ointments, pregnancy, reaction on vaccination,

Design outcomes

Primary

MeasureTime frame
Main Objective: 1. Test for equality between the spray (Polcortolon N Spray) and the ointment (Volonimat Salbe N) using the vasoconstiction test assay. 2. Classification of the corticosteroide in a strength class.;Secondary Objective: Skin tolerability using patch test assay.;Primary end point(s): Equaly testing of Polcortolon N Spray and Volominal Salbe N. Safety of the base of Polycortolon N Spray—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026