CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars - Full Text View

Sponsor:	Catalysis SL
Information provided by:	Catalysis SL
ClinicalTrials.gov Identifier:	NCT00993005

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 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 Hypertrophic Scars and Keloids 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 hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of adverse effects at week 12 (end of the treatment) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Photographs of lesions at week 12 (end of the treatment) [ Time Frame: 12 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 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

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received:	October 7, 2009
Last Updated:	December 7, 2010
Health Authority:	Cuba: Institutional Review Board

Keywords provided by Catalysis SL:

Hypertrophic scars
Keloids
Asian Gotu Kola
Asian Pennywort

Additional relevant MeSH terms:

Hypertrophy
Keloid
Cicatrix, Hypertrophic
Cicatrix
Pathological Conditions, Anatomical

Collagen Diseases
Connective Tissue Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 24, 2012