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Cicatrix Cream in Post Surgical Scars and Epidermic Burn

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT01018589
First received: November 20, 2009
Last updated: December 7, 2010
Last verified: December 2010
History of Changes

November 20, 2009
December 7, 2010
September 2009
December 2010   (final data collection date for primary outcome measure)
Reduction of the areas of lesions at 2 months (end of the treatment) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01018589 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cicatrix Cream in Post Surgical Scars and Epidermic Burn
Effect the Cicatrix Cream in in Treatment of Post Surgical Scars and 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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Post Surgical Scars
  • Epidermic Burn
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.
Experimental: A
Cicatrix cream
Intervention: Other: Cicatrix cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Cuba
 
NCT01018589
CAT-0904-CU
Yes
Edelisa Moredo Romo, Juan Manuel Marquez Pediatric Hospital
Catalysis SL
Not Provided
Principal Investigator: Edelisa Moredo Romo, MD Juan Manuel Marquez Pediatric Hospital
Catalysis SL
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP