CICATRIX in the Treatment of Recent Post-surgical Scars
Phase 3
Completed
- Conditions
- Post-surgical Scars
- Registration Number
- NCT00991367
- Lead Sponsor
- Catalysis SL
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Length of the post-surgical scar(s) measured by a millimetric ruler at week 4 (end of the treatment) 4 weeks
- Secondary Outcome Measures
Name Time Method Occurrence of adverse effects at week 4 (end of the treatment) 4 weeks Photographs of lesions at week 4 (end of the treatment) 4 weeks
Trial Locations
- Locations (1)
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
🇨🇺Havana City, Havana, Cuba
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital🇨🇺Havana City, Havana, Cuba