Back to resultsCicatrix Cream in Cutaneous Groves
Primary Purpose
Cutaneous Groves
Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
Cicatrix cream
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Groves focused on measuring Cutaneous Groves
Eligibility Criteria
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.
Sites / Locations
- Pediatric Hospital Juan Manuel Marquez
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Cicatrix cream
Outcomes
Primary Outcome Measures
They are the cutaneous grooves, being Observed the reduction of the number of the lesions monthly.
Secondary Outcome Measures
Extension of the groves and the reduction of these expressed in centimetres
Adverse effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01018212
Brief Title
Cicatrix Cream in Cutaneous Groves
Official Title
Effect the Cicatrix Cream in Cutaneous Groves Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Catalysis SL
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Groves
Keywords
Cutaneous Groves
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Cicatrix cream
Intervention Type
Other
Intervention Name(s)
Cicatrix cream
Intervention Description
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.
Primary Outcome Measure Information:
Title
They are the cutaneous grooves, being Observed the reduction of the number of the lesions monthly.
Time Frame
4 month
Secondary Outcome Measure Information:
Title
Extension of the groves and the reduction of these expressed in centimetres
Time Frame
4 months
Title
Adverse effects
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda Pastrana, MD
Organizational Affiliation
Pediatric Hospital Juan Manuel Marquez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Hospital Juan Manuel Marquez
City
Havana City
State/Province
Havana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
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Cicatrix Cream in Cutaneous Groves
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