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OpenTrials
Completed

NCT Number: NCT01018589

Cicatrix Cream in Post Surgical Scars 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.

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Key information

Conditions

Post Surgical Scars Epidermic Burn

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Juan Manuel Marquez Pediatric Hospital

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cicatrix cream

Other

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 outcomes

  1. Reduction of the areas of lesions at 2 months (end of the treatment)

    Time frame: 2 months

Secondary outcomes

  1. Coloration of the lesions at 2 months (end of the treatment)

    Time frame: 2 months

  2. Adverse effects

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 23, 2009
Registry last updated
Dec 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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