Clinical Trial: CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Hypertrophic Scars and Keloids Scars.
Brief Summary: The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons to be recruited and randomized for the study is 90.
Detailed Summary:
Sponsor: Catalysis SL
Current Primary Outcome: Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment) [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Occurrence of adverse effects at week 12 (end of the treatment) [ Time Frame: 12 weeks ]
- Photographs of lesions at week 12 (end of the treatment) [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Catalysis SL
Dates:
Date Received: October 7, 2009
Date Started: October 2009
Date Completion:
Last Updated: December 7, 2010
Last Verified: December 2010
