Cicatrix Cream in Cutaneous Groves

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT01018212
First received: November 20, 2009
Last updated: December 7, 2010
Last verified: December 2010

November 20, 2009
December 7, 2010
September 2009
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01018212 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cicatrix Cream in Cutaneous Groves
Effect the Cicatrix Cream in Cutaneous Groves Treatment

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cutaneous Groves
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.

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
50
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.
  • Responsible family not very cooperative.
Both
10 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Cuba
 
NCT01018212
CAT-0902-CU
Yes
Fernanda Pastrana, Pediatric Hospital Juan Manuel Márquez
Catalysis SL
Not Provided
Principal Investigator: Fernanda Pastrana, MD Pediatric Hospital Juan Manuel Marquez
Catalysis SL
December 2010

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