Cicatrix Cream in Post Surgical Scars 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect the Cicatrix Cream in in Treatment of Post Surgical Scars and and Epidermic Burn.|
- Reduction of the areas of lesions at 2 months (end of the treatment) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- Coloration of the lesions at 2 months (end of the treatment) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Adverse effects [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Other: Cicatrix cream
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018589
|Juan Manuel Marquez Pediatric Hospital|
|Havana City, Havana, Cuba, 10400|
|Principal Investigator:||Edelisa Moredo Romo, MD||Juan Manuel Marquez Pediatric Hospital|