Clinical study to approve the compatibility of Pyolysin®-Salbe in children having superfical wounds

Open clinical study to determine the compatibility of Pyolysin®-Salbe in children aged between 0 and 17 years during the dermatological treatment of superficial wounds - Clinical study Pyolysin®-Salbe in children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002755-34-DE

Enrollment

120

Registered

2011-11-09

Start date

2012-02-22

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Superficial wounds in children aged between 0 and 17 years such as wounds caused by scraping, abrasions, bagatell injuries

Interventions

Trade Name: Pyolysin®-Salbe Product Name: Pyolysin®-Salbe Pharmaceutical Form: Cutaneous spray, ointment INN or Proposed INN: Pyolysin Kulturfiltrat Concentration unit: g gram(s) Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age between 0-17 years bagatell injuries wounds caused by scraping superficial wounds outpatients sufficient german language skills the patient and/or the guarding should be able to keep the record in the study diary Are the trial subjects under 18? yes Number of subjects for this age range: 120 F.1.2 Adults (18-64 years) no 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: Age above 17 years Known incompatibility of the investigational product Infected/superinfected wounds Internal medication with antihistamines, antibiotics, analgetics or immunosuppressants inpatients severe atopic dermatitis Pregnancy women of child bearing potential not using contraception Patient and/or the guarding are not able to keep the records in the study diary Participation in other clinical trials

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At day 0, 7, 14, 21 Additionally it is investigated by the patients and/or the guarding every day after the application (twice) of the investigational product and noted in the study diary;Main Objective: To confirm the compatibility of the Pyolysin-Salbe in the age group from 0 to 17 years;Secondary Objective: Additional information on the wound healing process;Primary end point(s): Compatibility of the inversigational product Measured by visual scores considering the feeling of the skin after the application of the investigational product and the existence of pruritus. Furthermore the adapted SCORAD scoring is used	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: At day 0, 7, 14, 21 Additionally it is investigated by the patients and/or the guarding every day after the application (twice) of the investigational product and noted in the study diary;Main Objective: To confirm the compatibility of the Pyolysin-Salbe in the age group from 0 to 17 years;Secondary Objective: Additional information on the wound healing process;Primary end point(s): Compatibility of the inversigational product Measured by visual scores considering the feeling of the skin after the application of the investigational product and the existence of pruritus. Furthermore the adapted SCORAD scoring is used

—

Secondary

Measure	Time frame
Secondary end point(s): Additional information on the wound healing progress-efficacy;Timepoint(s) of evaluation of this end point: At day 0, 7, 14, 21	—

Countries

Germany

Contacts

Public ContactManaging Director

FORIM GmbH

spmueller@forim.de0049062140046027

Outcome results

None listed

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