Contractubex Treatment in Scars After Abdominal Caesarean Section (ConMex)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01112371|
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : April 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Scars||Drug: Contractubex||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
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|
- Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS]. [ Time Frame: Screening and 12 weeks ]The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively.
- Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS]. [ Time Frame: Screening and 6 weeks ]The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112371
|Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León|
|Monterrey Nuevo León, C.p., Mexico, 64460|
|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|