Cicatrix Cream in Post Surgical Scars and Epidermic Burn

Post Surgical Scars Clinical Trial

Official title:

Effect the Cicatrix Cream in in Treatment of Post Surgical Scars and and Epidermic Burn.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018589
• Other study ID #: CAT-0904-CU
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2009
• Last updated: December 7, 2010
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of epidermic burns or post surgical scars. The duration of this phase 2 clinical trial will be two months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patient with lesions characteristic of the investigated illness.

• Signed informed consent

Exclusion Criteria:

• Patient that refer manifestations of high sensibility to the medication or to some of the components of the product

• Patient that don't want to participate in the study

• Patient not very cooperative

• Family responsible not very cooperative

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Cicatrix
• Epidermic Burn
• Post Surgical Scars

Intervention

Other:
• Cicatrix cream
We will be carried out the topical application of the product (Cicatrix cream) in the epidermic burns or post surgical scars by administration fo the patients twice a day during two months to a dose of 0,1 ml of cream for each cm of surface, being controlled by the specialist in biweekly consultations. To the patient will be explained the technique of the application.

Locations

Country	Name	City	State
Cuba	Juan Manuel Marquez Pediatric Hospital	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of the areas of lesions at 2 months (end of the treatment)		2 months	Yes
Secondary	Coloration of the lesions at 2 months (end of the treatment)		2 months	No
Secondary	Adverse effects		2 months	Yes