Cicatrix Cream in Cutaneous Groves
The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of cutaneous grooves. The duration of this phase 2 clinical trial will be 4 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 Cutaneous Groves Treatment|
- They are the cutaneous grooves, being Observed the reduction of the number of the lesions monthly. [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
- Extension of the groves and the reduction of these expressed in centimetres [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Adverse effects [ Time Frame: 4 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 lesions auto administration three times a day during four months, being controlled by the specialist in months consultations.
The dose of 0,1 ml of cream for each cm. of surface, To the patient will be explained the technique of the application.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018212
|Pediatric Hospital Juan Manuel Marquez|
|Havana City, Havana, Cuba, 10400|
|Principal Investigator:||Fernanda Pastrana, MD||Pediatric Hospital Juan Manuel Marquez|