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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
  Purpose
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.

Condition Intervention Phase
Cutaneous Groves Other: Cicatrix cream Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect the Cicatrix Cream in Cutaneous Groves Treatment

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • They are the cutaneous grooves, being Observed the reduction of the number of the lesions monthly. [ Time Frame: 4 month ]

Secondary Outcome Measures:
  • Extension of the groves and the reduction of these expressed in centimetres [ Time Frame: 4 months ]
  • Adverse effects [ Time Frame: 4 months ]

Estimated Enrollment: 50
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Cicatrix cream
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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018212


Locations
Cuba
Pediatric Hospital Juan Manuel Marquez
Havana City, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Fernanda Pastrana, MD Pediatric Hospital Juan Manuel Marquez
  More Information

Responsible Party: Fernanda Pastrana, Pediatric Hospital Juan Manuel Márquez
ClinicalTrials.gov Identifier: NCT01018212     History of Changes
Other Study ID Numbers: CAT-0902-CU
First Submitted: November 20, 2009
First Posted: November 23, 2009
Last Update Posted: December 8, 2010
Last Verified: December 2010

Keywords provided by Catalysis SL:
Cutaneous Groves

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes