CICATRIX in the Treatment of Recent Post-surgical Scars

December 7, 2010 updated by: Catalysis SL

Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Recent Post-surgical Scars

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Havana
      • Havana City, Havana, Cuba, 10400
        • "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
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.
Experimental: A
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 Names:
  • Cosmetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of the post-surgical scar(s) measured by a millimetric ruler at week 4 (end of the treatment)
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse effects at week 4 (end of the treatment)
Time Frame: 4 weeks
4 weeks
Photographs of lesions at week 4 (end of the treatment)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Omara Lemus, MD, "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (Estimate)

October 8, 2009

Study Record Updates

Last Update Posted (Estimate)

December 8, 2010

Last Update Submitted That Met QC Criteria

December 7, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-0909-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-surgical Scars

Clinical Trials on Cicatrix

3
Subscribe