NCT00991367CompletedPhase 3
Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Recent Post-surgical Scars
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Catalysis SL
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Length of the post-surgical scar(s) measured by a millimetric ruler at week 4 (end of the treatment)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Length of the post-surgical scar(s) measured by a millimetric ruler at week 4 (end of the treatment)
Time Frame: 4 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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