Clinical trial NCT01112371: Contractubex Treatment in Scars After Abdominal Caesarean Section
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scars
Keywords: scars after abdominal Caesarean section
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS].
timeFrame: Screening and 12 weeks
Secondary outcomes:
measure: Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS].
timeFrame: Screening and 6 weeks
Other outcomes:
Locations:
city: Monterrey Nuevo León
country: Mexico
facility: Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León
state: C.p.
Study officials:
affiliation: Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León, Monterrey Nuevo León,C.P. 64460, Mexico
name: Jorge Ocampo Candiani, MD
role: PRINCIPAL_INVESTIGATOR
References:
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
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.