Double-randomized and controlled clinical trial in children to assess the efficacy and safety of Symphytum herb extract cream 10% against 1% in the acceleration of wound healing - Traumaplant-Childre

• Conditions: Wound healing

• Registration Number: EUCTR2008-002705-38-CZ
• Lead Sponsor: HARRAS Pharma Curarina Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Superfacial abrasions and wounds of the skin
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Injuries where topical therapy is inadequate and which have to be treated in other way:
1. Polytrauma patient and/or severe accident requiring surgical intervention
2. Target abrasion requiring surgical debridement and/or sutures
3. Deep and/or heavily bleeding wound
4. Already superinfected target abrasion
5. Microcirculatory disorders caused by systemic diseases (e.g. diabetes mellitus)
6. Pre-treatment with local drugs within 12 hours before inclusion in the study (exception: cleaning with water)
7. Patient with a known hypersensitivity against a component of the emulsion cream base: mono- and diglyceride of palmitic and stearic acid, polyoxylethylene-glycerole-monostearate, isopropylmyristate, propyleneglycol, 2-octyldodecanol, dimeticone, alpha-tocopherol acetate, rosemary oil, citric acid, preservatives, 2-hydroxyethyl salicylate, sorbic acid)
8. Allergic, infectious, or inflammatory skin disease in the area of application

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy and time in the acceleration of wound healing in children ;Secondary Objective: Local tolerability on the skin;Primary end point(s): Healing (epithelising) effect by measuring of the area of abrasion before and after tratment (the rate of abrasion decrease degree).