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Cicatrix Cream in Cutaneous Groves

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018212
First Posted: November 23, 2009
Last Update Posted: December 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Catalysis SL
November 20, 2009
November 23, 2009
December 8, 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 ]
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 ]
  • Adverse effects [ Time Frame: 4 months ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
Sexes Eligible for Study: All
10 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Cuba
 
 
NCT01018212
CAT-0902-CU
Yes
Not Provided
Not Provided
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