CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars

Phase 3

Completed

• Conditions: Hypertrophic Scars; Keloids
• Interventions: Other: Cicatrix; Other: Placebo

• Registration Number: NCT00993005
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• 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

• Hypertrophic wound or keloid with no treatment for more than 1 month.
• Signed informed consent.

Exclusion Criteria

• 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 hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital; 🇨🇺 Havana City, Havana, Cuba