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

Phase 1

• Conditions: Superficial wounds in children aged between 0 and 17 years such as wounds caused by scraping, abrasions, bagatell injuries; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-002755-34-DE
• Lead Sponsor: Serumwerk Bernburg AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-09
• Study Completion: 2014-11-03
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified