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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
  Purpose

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.


Condition Intervention Phase
Post Surgical Scars
Epidermic Burn
 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 in Treatment of Post Surgical Scars and and Epidermic Burn.

Resource links provided by NLM:

MedlinePlus related topics: Burns Scars
U.S. FDA Resources

Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • Reduction of the areas of lesions at 2 months (end of the treatment) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
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 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018589

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

No publications provided

Responsible Party: Edelisa Moredo Romo, Juan Manuel Marquez Pediatric Hospital
ClinicalTrials.gov Identifier: NCT01018589     History of Changes
Other Study ID Numbers: CAT-0904-CU
Study First Received: November 20, 2009
Last Updated: December 7, 2010
Health Authority: Cuba: Institutional Review Board

Keywords provided by Catalysis SL:
Post surgical scars
Epidermic burn
Cicatrix cream

Additional relevant MeSH terms:
Burns
Cicatrix
Wounds and Injuries
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013