- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00993005
CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars
December 7, 2010 updated by: Catalysis SL
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Havana
-
Havana City, Havana, Cuba, 10400
- "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hypertrophic wound or keloid with no treatment for more than 1 month.
- Signed informed consent.
Exclusion Criteria:
- Usage of steroids within 30 days.
- Malignant neoplastic conditions.
- Alcoholism.
- Handicap and/or psychiatric condition preventing treatment accomplishment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: B
Placebo
|
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.
|
Experimental: A
Cicatrix
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of adverse effects at week 12 (end of the treatment)
Time Frame: 12 weeks
|
12 weeks
|
Photographs of lesions at week 12 (end of the treatment)
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Omara Lemus, MD, "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
October 7, 2009
First Submitted That Met QC Criteria
October 8, 2009
First Posted (Estimate)
October 9, 2009
Study Record Updates
Last Update Posted (Estimate)
December 8, 2010
Last Update Submitted That Met QC Criteria
December 7, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAT-0910-CU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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