Doppelblinder, randomisierter, vehikel- und referenzkontrollierter Nachweis der antibakteriellen Wirksamkeit von Kaliumpermanganat(0,001%)-enthaltenden topischen Präparationen zur epikutanen Applikation Double blind, randomised, vehicle- and reference controlled study of the antibacterial efficacy of Kaliumpermanganat (0.001%)-containing topical preparations for cutaneous application - Antibakterieller Nachweis von Kaliumpermanganat-enthaltenden topischen Präparationen

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003740-22-DE

Enrollment

Registered

2005-01-31

Start date

2005-04-08

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Objective of the trial is the testing of the antibacterial efficacy of a Kaliumpermanaganat (0.001%)-containing topical preparation for cutaneous application in healthy volunteers

Interventions

Product Name: Kaliumpermanganat (0.001%=Active Substance) Pharmaceutical Form: Cutaneous liquid INN or Proposed INN: Kaliumpermanaganat Concentration unit: % percent Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -voluntary participation only -volunteers 18-50 years of age -no systemic medication (except for oral contraceptives) for at least 8 weeks prior to the start of the study -no topical therapy for at least 8 weeks prior to the study start -no topical application of cosmetics and / or other products of skin care in the area of the back for at least 1 week prior to the start of the study -written informed consent of the volunteer after detailed information about the caracter, risks and scope of the clinical trial 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -existence of a chronic inflammatory skin or systemic disease influencing the barrier function of the skin -volunteers suffering from intolerability or hypersensitization towards one of the active ingredients of the preparations used or towards the cutaneous test bandages -volunteers suffering from one of the following diseases: (1) immune suppression; (2) transplantation (except auto-transplanatation) -pregnant or breastfeeding women -unreliability or lack of co-operation of volunteers

Design outcomes

Primary

Measure	Time frame
Main Objective: Determination of the antibacterial efficacy of a Kaliumpermanganat (0.001%)-containing topical preparation for cutaneous use in healthy volunteers;Secondary Objective: none ;Primary end point(s): Primary target parameter of the study is the reduction in the number of bacterial colonies (number of bacterial cultures)	—

Countries

Germany

Outcome results

None listed

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