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Cicatrix Cream in Post Surgical Scars and Epidermic Burn

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ClinicalTrials.gov Identifier: NCT01018589
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : December 8, 2010
Sponsor:
Information provided by:
Catalysis SL

Brief Summary:
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 or disease Intervention/treatment Phase
Post Surgical Scars Epidermic Burn Other: Cicatrix cream Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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.
Study Start Date : September 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

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

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.




Primary Outcome Measures :
  1. Reduction of the areas of lesions at 2 months (end of the treatment) [ Time Frame: 2 months ]

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


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Edelisa Moredo Romo, Juan Manuel Marquez Pediatric Hospital
ClinicalTrials.gov Identifier: NCT01018589     History of Changes
Other Study ID Numbers: CAT-0904-CU
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: December 2010

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

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