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
  Purpose

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.


Condition Intervention Phase
Scars
Drug: Contractubex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 61
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contractubex 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.
No Intervention: Non treatment

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112371

Locations
Mexico
Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León
Monterrey Nuevo León, C.p., Mexico, 64460
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
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
  More Information

Publications:
Ocampo-Candiani J, et al. Efficacy of a topical gel containing extractum cepae, allantoin and heparin in the treatment of abdominal caesarean section scars. IMCAS Annual Meeting 2013. www.imcas.com/en/imcas2013/schedule/lecture/id/5971

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01112371     History of Changes
Other Study ID Numbers: MRZ 90011_4023_1
Study First Received: April 6, 2010
Last Updated: April 7, 2014
Health Authority: Mexico: Ministry of Health

Keywords provided by Merz Pharmaceuticals GmbH:
scars after abdominal Caesarean section

Additional relevant MeSH terms:
Allantoin
Heparin
Anticoagulants
Cardiovascular Agents
Dermatologic Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014