Back to resultsCicatrix Cream in Post Surgical Scars and Epidermic Burn
Primary Purpose
Post Surgical Scars, Epidermic Burn
Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
Cicatrix cream
Sponsored by
About this trial
This is an interventional treatment trial for Post Surgical Scars focused on measuring Post surgical scars, Epidermic burn, Cicatrix cream
Eligibility Criteria
Inclusion Criteria:
- Patient with lesions characteristic of the investigated illness.
- Signed informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Juan Manuel Marquez Pediatric Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Cicatrix cream
Outcomes
Primary Outcome Measures
Reduction of the areas of lesions at 2 months (end of the treatment)
Secondary Outcome Measures
Coloration of the lesions at 2 months (end of the treatment)
Adverse effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01018589
Brief Title
Cicatrix Cream in Post Surgical Scars and Epidermic Burn
Official Title
Effect the Cicatrix Cream in in Treatment of Post Surgical Scars and and Epidermic Burn.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Surgical Scars, Epidermic Burn
Keywords
Post surgical scars, Epidermic burn, Cicatrix cream
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Cicatrix cream
Intervention Type
Other
Intervention Name(s)
Cicatrix cream
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of the areas of lesions at 2 months (end of the treatment)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Coloration of the lesions at 2 months (end of the treatment)
Time Frame
2 months
Title
Adverse effects
Time Frame
2 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with lesions characteristic of the investigated illness.
Signed informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edelisa Moredo Romo, MD
Organizational Affiliation
Juan Manuel Marquez Pediatric Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juan Manuel Marquez Pediatric Hospital
City
Havana City
State/Province
Havana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
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Cicatrix Cream in Post Surgical Scars and Epidermic Burn
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