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OpenTrials
Completed

NCT Number: NCT01018212

Cicatrix Cream in Cutaneous Groves

The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of cutaneous grooves. The duration of this phase 2 clinical trial will be 4 months.

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Key information

Conditions

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pediatric Hospital Juan Manuel Marquez

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

  • 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.
  • Responsible family 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 lesions auto administration three times a day during four months, being controlled by the specialist in months consultations.

The dose of 0,1 ml of cream for each cm. of surface, To the patient will be explained the technique of the application.

Primary outcomes

  1. They are the cutaneous grooves, being Observed the reduction of the number of the lesions monthly.

    Time frame: 4 month

Secondary outcomes

  1. Extension of the groves and the reduction of these expressed in centimetres

    Time frame: 4 months

  2. Adverse effects

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Effect the Cicatrix Cream in Cutaneous Groves Treatment

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.