CICATRIX in the Treatment of Recent Post-surgical Scars - Full Text View

Sponsor:	Catalysis SL
Information provided by:	Catalysis SL
ClinicalTrials.gov Identifier:	NCT00991367

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:

MedlinePlus related topics: Scars

U.S. FDA Resources

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 May 24, 2012