Contractubex Treatment in Scars After Abdominal Caesarean Section

NCT01112371 | Completed Phase 4

• 1 other identifier: MRZ 90011_4023_1
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Scars

Keywords

scars after abdominal Caesarean section

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS].

  Screening and 6 weeks

Study Arms (2)

Contractubex

EXPERIMENTAL

Drug: Contractubex

Non treatment

NO INTERVENTION

Interventions

Contractubex DRUG

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.

Also known as: Other names have not been specified.

Contractubex

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (1)

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

Monterrey Nuevo León, C.p., 64460, Mexico

Location

Related 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

  RESULT

• 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.

  PMID: 24509969 RESULT

MeSH Terms

Conditions

Cicatrix

Interventions

allantoin, heparin, onion extract drug combination

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 28, 2010
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

ME (1)