Contractubex Treatment in Scars After Abdominal Caesarean Section

Scars Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112371
• Other study ID #: MRZ 90011_4023_1
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2010
• Last updated: April 7, 2014
• Start date: February 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2014
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scars

Intervention

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.

Locations

Country	Name	City	State
Mexico	Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León	Monterrey Nuevo León	C.p.

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

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

Ocampo-Candiani J, Vázquez-Martínez 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 compa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Screening and 12 weeks	No
Secondary	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.	Screening and 6 weeks	No