ScarsPhase 4ConMexNCT01112371
Contractubex Treatment in Scars After Abdominal Caesarean Section
A Phase 4 study testing Contractubex in people with Scars, run by Merz Pharmaceuticals GmbH at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Scars
- What is being tested?
- Contractubex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2011to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León
Monterrey Nuevo León, C.p., 64460
About this study
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
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
- Being tested
- Contractubex
- Keywords
- scars after abdominal Caesarean section
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContractubexDrug
Also called Other names have not been specified.
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.
| Study group | Role | What they receive |
|---|---|---|
| Contractubex | Experimental | Not described Receives: Drug: Contractubex |
| Non treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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].
The scale consists of two numeric scales which need to be filled out by the observer and the patient, respectively.
Measured: Screening and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge Ocampo Candiani, MD, Principal investigator, Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León, Monterrey Nuevo León,C.P. 64460, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112371
- Sponsor's protocol ID
- MRZ 90011_4023_1
- Acronym
- ConMex
- Status last verified
- Apr 2014
- First submitted
- 6 Apr 2010
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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, 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.
PubMed 24509969
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01112371
- Acronym / sponsor ID
- ConMex / MRZ 90011_4023_1
- Conditions
- Scars
- Keywords
- scars after abdominal Caesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contractubex | Experimental | Drug: Contractubex |
| Non treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ContractubexAlso: Other names have not been specified.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. | Drug | Contractubex |
Primary outcome
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.
1 secondary outcome
Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS].
Time frame: Screening and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Results publicationOcampo-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
- Results publication: PubMed 24509969Ocampo-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Ocampo Candiani, MD principal investigator
Jefe del Departamento Dermatologia, Facultad de medicina y Hospital Universitario, Universidad Autonoma de Nuevo León, Monterrey Nuevo León,C.P. 64460, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contractubex in people with Scars, run by Merz Pharmaceuticals GmbH at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance of the scars will be evaluated by use of the Patient and Observer Scar Assessment Scale [POSAS]. (time frame: Screening and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112371, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.