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
  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: 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

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Fernanda Pastrana, Pediatric Hospital Juan Manuel Márquez
ClinicalTrials.gov Identifier: NCT01018212     History of Changes
Other Study ID Numbers: CAT-0902-CU
Study First Received: November 20, 2009
Last Updated: December 7, 2010
Health Authority: Cuba: Institutional Review Board

Keywords provided by Catalysis SL:
Cutaneous Groves

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014