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Cicatrix Cream in Post Surgical Scars and Epidermic Burn

This study has been completed.
Information provided by:
Catalysis SL Identifier:
First received: November 20, 2009
Last updated: December 7, 2010
Last verified: December 2010
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: Intervention Model: Single Group Assignment
Masking: None (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:

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 ]

Secondary Outcome Measures:
  • Coloration of the lesions at 2 months (end of the treatment) [ Time Frame: 2 months ]
  • Adverse effects [ Time Frame: 2 months ]

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.


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

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
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 identifier: NCT01018589

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

Responsible Party: Edelisa Moredo Romo, Juan Manuel Marquez Pediatric Hospital Identifier: NCT01018589     History of Changes
Other Study ID Numbers: CAT-0904-CU
Study First Received: November 20, 2009
Last Updated: December 7, 2010

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

Additional relevant MeSH terms:
Wounds and Injuries
Pathologic Processes processed this record on August 18, 2017