CICATRIX in the Treatment of Recent Post-surgical Scars
This study has been completed.
Sponsor:
Catalysis SL
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00991367
First received: October 7, 2009
Last updated: December 7, 2010
Last verified: December 2010
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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:
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 June 18, 2013