Post Surgical ScarsPhase 2NCT01018589
Cicatrix Cream in Post Surgical Scars and Epidermic Burn
A Phase 2 study testing Cicatrix cream in people with Post Surgical Scars and Epidermic Burn, run by Catalysis SL at 1 site in Cuba.
Trial summary
The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of epidermic burns or post surgical scars. The duration of this phase 2 clinical trial will be two months. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Post Surgical Scars, Epidermic Burn
- What is being tested?
- Cicatrix cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCuba
- Study dates
- Sep 2009to Dec 2010
- Phase
- Phase 2
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient with lesions characteristic of the investigated illness.
- Signed informed consent
Who cannot join
- Patient that refer manifestations of high sensibility to the medication or to some of the components of the product
- Patient that don't want to participate in the study
- Patient not very cooperative
- Family responsible not very cooperative
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect the Cicatrix Cream in in Treatment of Post Surgical Scars and and Epidermic Burn.
The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of epidermic burns or post surgical scars. The duration of this phase 2 clinical trial will be two months.
- Conditions
- Post Surgical Scars, Epidermic Burn
- Being tested
- Cicatrix cream
- Keywords
- Post surgical scars, Epidermic burn, Cicatrix cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cicatrix creamOther
We will be carried out the topical application of the product (Cicatrix cream) in the epidermic burns or post surgical scars by administration fo the patients twice a day during two months to a dose of 0,1 ml of cream for each cm of surface, being controlled by the specialist in biweekly consultations.
To the patient will be explained the technique of the application.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Cicatrix cream Receives: Other: Cicatrix cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the areas of lesions at 2 months (end of the treatment)
Measured: 2 months
Secondary outcomes (2)
Coloration of the lesions at 2 months (end of the treatment)
Measured: 2 months
Adverse effects
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Surgical 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edelisa Moredo Romo, MD, Principal investigator, Juan Manuel Marquez Pediatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018589
- Sponsor's protocol ID
- CAT-0904-CU
- Status last verified
- Dec 2010
- First submitted
- 20 Nov 2009
- Last updated
- 8 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect the Cicatrix Cream in in Treatment of Post Surgical Scars and and Epidermic Burn.
- ClinicalTrials.gov ID
- NCT01018589
- Acronym / sponsor ID
- CAT-0904-CU
- Conditions
- Post Surgical Scars, Epidermic Burn
- Keywords
- Post surgical scars, Epidermic burn, Cicatrix cream
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Nov 2009 (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 the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of epidermic burns or post surgical scars. The duration of this phase 2 clinical trial will be two months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Cicatrix creamCicatrix cream |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patient with lesions characteristic of the investigated illness.
- Signed informed consent
Key exclusion criteria (4 listed)
- Patient that refer manifestations of high sensibility to the medication or to some of the components of the product
- Patient that don't want to participate in the study
- Patient not very cooperative
- Family responsible not very cooperative
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 |
|---|---|---|
| Cicatrix creamWe will be carried out the topical application of the product (Cicatrix cream) in the epidermic burns or post surgical scars by administration fo the patients twice a day during two months to a dose of 0,1 ml of cream for each cm of surface, being controlled by the specialist in biweekly consultations. To the patient will be explained the technique of the application. | Other | A |
Primary outcome
Reduction of the areas of lesions at 2 months (end of the treatment)
Time frame: 2 months
2 secondary outcomes
Coloration of the lesions at 2 months (end of the treatment)
Time frame: 2 months
Adverse effects
Time frame: 2 months
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 Dec 2010.
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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.
Edelisa Moredo Romo, MD principal investigator
Juan Manuel Marquez Pediatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cicatrix cream in people with Post Surgical Scars and Epidermic Burn, run by Catalysis SL at 1 site in Cuba.
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 2 inclusion and 4 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 Dec 2010. 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 Cuba. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reduction of the areas of lesions at 2 months (end of the treatment) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2010.