Back to resultsCICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars
Primary Purpose
Hypertrophic Scars, Keloids
Status
Completed
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
Cicatrix
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophic Scars focused on measuring Hypertrophic scars, Keloids, Asian Gotu Kola, Asian Pennywort
Eligibility Criteria
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.
Sites / Locations
- "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Cicatrix
Placebo
Outcomes
Primary Outcome Measures
Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)
Secondary Outcome Measures
Occurrence of adverse effects at week 12 (end of the treatment)
Photographs of lesions at week 12 (end of the treatment)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00993005
Brief Title
CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars
Official Title
Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Hypertrophic Scars and Keloids Scars.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Catalysis SL
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. The estimated number of persons to be recruited and randomized for the study is 90.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scars, Keloids
Keywords
Hypertrophic scars, Keloids, Asian Gotu Kola, Asian Pennywort
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Cicatrix
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Other
Intervention Name(s)
Cicatrix
Other Intervention Name(s)
Cosmetic
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Occurrence of adverse effects at week 12 (end of the treatment)
Time Frame
12 weeks
Title
Photographs of lesions at week 12 (end of the treatment)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omara Lemus, MD
Organizational Affiliation
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
City
Havana City
State/Province
Havana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
Learn more about this trial
CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars
We'll reach out to this number within 24 hrs