Hypertrophic ScarsPhase 3NCT00993005
CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars
A Phase 3 study testing Cicatrix in people with Hypertrophic Scars and Keloids, run by Catalysis SL at 1 site in Cuba.
Trial summary
The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hypertrophic Scars, Keloids
- What is being tested?
- Cicatrix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCuba
- Study dates
- Oct 2009to Dec 2010
- Phase
- Phase 3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hypertrophic wound or keloid with no treatment for more than 1 month.
- Signed informed consent.
Who cannot join
- Usage of steroids within 30 days.
- Malignant neoplastic conditions.
- Alcoholism.
- Handicap and/or psychiatric condition preventing treatment accomplishment.
Trial locations and contacts
1 site in 1 country.
Cuba1 site
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Havana, La Habana, 10400
About this study
Official title: Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Hypertrophic Scars and Keloids Scars.
The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons to be recruited and randomized for the study is 90.
- Conditions
- Hypertrophic Scars, Keloids
- Being tested
- Cicatrix, Placebo
- Keywords
- Hypertrophic scars, Keloids, Asian Gotu Kola, Asian Pennywort
- Medical subject headings
- Cicatrix, Hypertrophic, Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CicatrixOther
Also called Cosmetic
Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of CICATRIX (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 12 weeks.
PlaceboOther
Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Cicatrix Receives: Other: Cicatrix |
| B | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)
Measured: 12 weeks
Secondary outcomes (2)
Occurrence of adverse effects at week 12 (end of the treatment)
Measured: 12 weeks
Photographs of lesions at week 12 (end of the treatment)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startOct 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 Hypertrophic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Omara Lemus, MD, Principal investigator, "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993005
- Sponsor's protocol ID
- CAT-0910-CU
- Status last verified
- Dec 2010
- First submitted
- 7 Oct 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
- Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Hypertrophic Scars and Keloids Scars.
- ClinicalTrials.gov ID
- NCT00993005
- Acronym / sponsor ID
- CAT-0910-CU
- Conditions
- Hypertrophic Scars, Keloids
- Keywords
- Hypertrophic scars, Keloids, Asian Gotu Kola, Asian Pennywort
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Oct 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 efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons to be recruited and randomized for the study is 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: CicatrixCicatrix |
| B | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Hypertrophic wound or keloid with no treatment for more than 1 month.
- Signed informed consent.
Key exclusion criteria (4 listed)
- Usage of steroids within 30 days.
- Malignant neoplastic conditions.
- Alcoholism.
- Handicap and/or psychiatric condition preventing treatment accomplishment.
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 |
|---|---|---|
| CicatrixAlso: CosmeticDosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of CICATRIX (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 12 weeks. | Other | A |
| PlaceboDosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 4 weeks. | Other | B |
Primary outcome
Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)
Time frame: 12 weeks
2 secondary outcomes
Occurrence of adverse effects at week 12 (end of the treatment)
Time frame: 12 weeks
Photographs of lesions at week 12 (end of the treatment)
Time frame: 12 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 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.
Omara Lemus, MD principal investigator
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cicatrix in people with Hypertrophic Scars and Keloids, 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment) (time frame: 12 weeks). 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.