Contractubex Treatment in Scars After Abdominal Caesarean Section (ConMex)
This study has been completed.
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
First received: April 6, 2010
Last updated: February 27, 2013
Last verified: February 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2012 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112371
|Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León
|Monterrey Nuevo León, C.p., Mexico, 64460 |
Merz Pharmaceuticals GmbH
||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
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
||Merz Pharmaceuticals GmbH
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 6, 2010
||February 27, 2013
||Mexico: Ministry of Health
Keywords provided by Merz Pharmaceuticals GmbH:
scars after abdominal Caesarean section
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2013
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action