Cicatrix Cream in Post Surgical Scars and Epidermic Burn

December 7, 2010 updated by: Catalysis SL

Effect the Cicatrix Cream in in Treatment of Post Surgical Scars and and Epidermic Burn.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Havana City, Havana, Cuba, 10400
        • Juan Manuel Marquez Pediatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of the areas of lesions at 2 months (end of the treatment)
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Coloration of the lesions at 2 months (end of the treatment)
Time Frame: 2 months
2 months
Adverse effects
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Edelisa Moredo Romo, MD, Juan Manuel Marquez Pediatric Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (Estimate)

November 23, 2009

Study Record Updates

Last Update Posted (Estimate)

December 8, 2010

Last Update Submitted That Met QC Criteria

December 7, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-0904-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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