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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014