CICATRIX in the Treatment of Recent Post-surgical Scars

Phase 3

Completed

• Conditions: Post-surgical Scars
• Interventions: Other: Cicatrix; Other: Placebo

• 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

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-08
• Status Verified: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-08

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

Arm && Interventions

Group	Intervention	Description
A	Cicatrix	Cicatrix
B	Placebo	Placebo

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