CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars
Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Hypertrophic Scars and Keloids Scars.
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 7, 2009
CompletedFirst Posted
Study publicly available on registry
October 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 8, 2010
December 1, 2010
1.2 years
October 7, 2009
December 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)
12 weeks
Secondary Outcomes (2)
Occurrence of adverse effects at week 12 (end of the treatment)
12 weeks
Photographs of lesions at week 12 (end of the treatment)
12 weeks
Study Arms (2)
A
EXPERIMENTALCicatrix
B
PLACEBO COMPARATORPlacebo
Interventions
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.
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 Criteria
You may qualify if:
- Hypertrophic wound or keloid with no treatment for more than 1 month.
- Signed informed consent.
You may not qualify if:
- Usage of steroids within 30 days.
- Malignant neoplastic conditions.
- Alcoholism.
- Handicap and/or psychiatric condition preventing treatment accomplishment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Catalysis SLlead
Study Sites (1)
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Havana, La Habana, 10400, Cuba
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omara Lemus, MD
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2009
First Posted
October 9, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
December 8, 2010
Record last verified: 2010-12