We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00993005
First Posted: October 9, 2009
Last Update Posted: December 8, 2010
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.
Information provided by:
Catalysis SL
  Purpose
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.

Condition Intervention Phase
Hypertrophic Scars Keloids Other: Cicatrix Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Hypertrophic Scars and Keloids Scars.

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • 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 ]

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 scar rubbing in different directions for 2 minutes, three times a day, for 12 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 scar rubbing in different directions for 2 minutes, three times a day, for 4 weeks.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993005


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

Responsible Party: Alfredo Abreu Daniel, "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
ClinicalTrials.gov Identifier: NCT00993005     History of Changes
Other Study ID Numbers: CAT-0910-CU
First Submitted: October 7, 2009
First Posted: October 9, 2009
Last Update Posted: December 8, 2010
Last Verified: December 2010

Keywords provided by Catalysis SL:
Hypertrophic scars
Keloids
Asian Gotu Kola
Asian Pennywort

Additional relevant MeSH terms:
Hypertrophy
Keloid
Cicatrix
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Fibrosis
Pathologic Processes