Contractubex Treatment in Scars After Abdominal Caesarean Section (ConMex)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01112371
First received: April 6, 2010
Last updated: April 7, 2014
Last verified: April 2014

April 6, 2010
April 7, 2014
February 2011
February 2012   (final data collection date for primary outcome measure)
Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS]. [ Time Frame: Screening and 12 weeks ] [ Designated as safety issue: No ]
The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively.
Same as current
Complete list of historical versions of study NCT01112371 on ClinicalTrials.gov Archive Site
Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS]. [ Time Frame: Screening and 6 weeks ] [ Designated as safety issue: No ]
The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively.
Same as current
Not Provided
Not Provided
 
Contractubex Treatment in Scars After Abdominal Caesarean Section
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Scars
Drug: Contractubex

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.

Other Name: Other names have not been specified.
  • Experimental: Contractubex
    Intervention: Drug: Contractubex
  • No Intervention: Non treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01112371
MRZ 90011_4023_1
No
Merz Pharmaceuticals GmbH
Merz Pharmaceuticals GmbH
Not Provided
Principal Investigator: Jorge Ocampo Candiani, MD Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León, Monterrey Nuevo León,C.P. 64460, Mexico
Merz Pharmaceuticals GmbH
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP