Contractubex Treatment in Scars After Abdominal Caesarean Section

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of Contractubex® Gel, containing extractum cepae, allantoin and heparin, in the treatment of scars after abdominal Caesarean section compared to untreated scars after abdominal Caesarean section.

Official Title
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A Prospective, Single-center, Randomized, Parallel Group Trial to Investigate the Efficacy of Contractubex® Gel, Containing Extractum Cepae, Allantoin, and Heparin, in Scars After Abdominal Caesarean Section

Conditions
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Scars

Intervention / Treatment
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* Drug: Contractubex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females having given birth via elective abdominal Caesarean section for the first time within the last 5 to 10 days who had their suture removed (removed at screening). Age: 18 years or older. The subject must be willing and must be able to complete the entire course of the trial and to comply with the trial instructions. Written informed consent has been obtained from the subject. Females using suitable contraceptions. Exclusion Criteria: Use of any inadmissible medication, e.g. systemic corticosteroids, systemic immunosuppressants (such as cytostatics, therapy with antibodies, biologics, interferone, mykophenolatmofetil, methotrexate, cyclosporine, azathioprine). Any additional topical treatment in the area of the lower abdomen, regardless of the mode of action. Any other planned topical treatment in the lower part of the abdomen during the course of the trial. Any infection or wound in the area to treat. History of keloids or hypertrophic scars. Any severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or medical history of HIV infection. Any tumor diseases in the abdominal region independent of their dignity. Females having given birth via emergency abdominal Caesarean section. Psychiatric problems which, in the investigator's opinion, are severe enough to interfere with the trial results. Participation in another clinical trial within 30 days prior to screening. Evidence or suspicion that the subject might not comply with the study directives and/or that she is not reliable or trustworthy. Evidence or suspicion that the subject is not willing or unable to understand the information given to her as part of the informed consent, in particular regarding the risks and discomfort to which she would agree to be exposed. Previous participation in this clinical study. Known allergy or hypersensitivity to the study drug(s) or one of the ingredients of the formulation. Subjects who are imprisoned or are lawfully kept in an institution. Employees or direct relatives of an employee of the CRO, the study center or Merz Pharmaceuticals.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contractubex<br> | Drug: Contractubex<br>* Contractubex® Gel, containing 10% extractum cepae, 1% allantoin and 50/U of sodium heparin per one gram of gel. Active drug group: The gel will be applied twice daily (morning/evening). Approximately 2 cm of the IMP are applied onto the scar by light massage rubbing carefully until the product is worked in.<br>* Other names: Other names have not been specified.;|
| No Intervention: Non treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS]. | The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively. | Screening and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS]. | The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively. | Screening and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scars after abdominal Caesarean section