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CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00993005
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : December 8, 2010
Sponsor:
Information provided by:
Catalysis SL

Tracking Information
First Submitted Date  ICMJE October 7, 2009
First Posted Date  ICMJE October 9, 2009
Last Update Posted Date December 8, 2010
Study Start Date  ICMJE October 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2009)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00993005 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2009)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertrophic Scars
  • Keloids
Intervention  ICMJE
  • Other: Cicatrix
    Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of CICATRIX (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 12 weeks.
    Other Name: Cosmetic
  • Other: Placebo
    Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 4 weeks.
Study Arms  ICMJE
  • Experimental: A
    Cicatrix
    Intervention: Other: Cicatrix
  • Placebo Comparator: B
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 8, 2009)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hypertrophic wound or keloid with no treatment for more than 1 month.
  • Signed informed consent.

Exclusion Criteria:

  • Usage of steroids within 30 days.
  • Malignant neoplastic conditions.
  • Alcoholism.
  • Handicap and/or psychiatric condition preventing treatment accomplishment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cuba
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00993005
Other Study ID Numbers  ICMJE CAT-0910-CU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alfredo Abreu Daniel, "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Study Sponsor  ICMJE Catalysis SL
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Omara Lemus, MD "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
PRS Account Catalysis SL
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP