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Contractubex Treatment in Scars After Abdominal Caesarean Section (ConMex)

Primary Purpose

Scars

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Contractubex
Sponsored by
Merz Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scars focused on measuring scars after abdominal Caesarean section

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Contractubex

Non treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 6, 2010
Last Updated
April 7, 2014
Sponsor
Merz Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01112371
Brief Title
Contractubex Treatment in Scars After Abdominal Caesarean Section
Acronym
ConMex
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scars
Keywords
scars after abdominal Caesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contractubex
Arm Type
Experimental
Arm Title
Non treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Contractubex
Other Intervention Name(s)
Other names have not been specified.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS].
Description
The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively.
Time Frame
Screening and 12 weeks
Secondary Outcome Measure Information:
Title
Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS].
Description
The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively.
Time Frame
Screening and 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Ocampo Candiani, MD
Organizational Affiliation
Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León, Monterrey Nuevo León,C.P. 64460, Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León
City
Monterrey Nuevo León
State/Province
C.p.
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result
PubMed Identifier
24509969
Citation
Ocampo-Candiani J, Vazquez-Martinez OT, Iglesias Benavides JL, Buske K, Lehn A, Acker C. The prophylactic use of a topical scar gel containing extract of Allium cepae, allantoin, and heparin improves symptoms and appearance of cesarean-section scars compared with untreated scars. J Drugs Dermatol. 2014 Feb;13(2):176-82.
Results Reference
result

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Contractubex Treatment in Scars After Abdominal Caesarean Section

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