Cicatrix Cream in Cutaneous Groves

Cutaneous Groves Clinical Trial

Official title:

Effect the Cicatrix Cream in Cutaneous Groves Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018212
• Other study ID #: CAT-0902-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 cutaneous grooves. The duration of this phase 2 clinical trial will be 4 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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.

• Responsible family not very cooperative.

Study Design

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

Related Conditions & MeSH terms

• Cutaneous Groves

Intervention

Other:
• Cicatrix cream
We will be carried out the topical application of the product (Cicatrix cream) in the lesions auto administration three times a day during four months, being controlled by the specialist in months consultations. The dose of 0,1 ml of cream for each cm. of surface, To the patient will be explained the technique of the application.

Locations

Country	Name	City	State
Cuba	Pediatric Hospital Juan Manuel Marquez	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	They are the cutaneous grooves, being Observed the reduction of the number of the lesions monthly.		4 month	Yes
Secondary	Extension of the groves and the reduction of these expressed in centimetres		4 months	Yes
Secondary	Adverse effects		4 months	Yes