CICATRIX in the Treatment of Recent Post-surgical Scars

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00991367
First received: October 7, 2009
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of recent post-surgical scars. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of persons to be recruited and randomized for the study is 90.


Condition Intervention Phase
Post-surgical Scars
Other: Cicatrix
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Recent Post-surgical Scars

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • Length of the post-surgical scar(s) measured by a millimetric ruler at week 4 (end of the treatment) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of adverse effects at week 4 (end of the treatment) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Photographs of lesions at week 4 (end of the treatment) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Cicatrix
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 lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.
Other Name: Cosmetic
Placebo Comparator: B
Placebo
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 lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recent (less than 48 hours) post-surgical wound

Exclusion Criteria:

  • Post-surgical wound with sepsis
  • Usage of steroids within 30 days
  • Malignant neoplastic conditions
  • Alcoholism
  • Handicap and/or psychiatric condition preventing treatment accomplishment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991367

Locations
Cuba
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Havana City, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Omara Lemus, MD "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
  More Information

No publications provided

Responsible Party: Alfredo Abreu Daniel PhD, "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
ClinicalTrials.gov Identifier: NCT00991367     History of Changes
Other Study ID Numbers: CAT-0909-CU
Study First Received: October 7, 2009
Last Updated: December 7, 2010
Health Authority: Cuba: Institutional Review Board

Keywords provided by Catalysis SL:
Post-surgical scars
Asian Gotu Kola
Asian Pennywort

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014