Cicatrix Cream in Cutaneous Groves
Effect the Cicatrix Cream in Cutaneous Groves Treatment
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 20, 2009
CompletedFirst Posted
Study publicly available on registry
November 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 8, 2010
December 1, 2010
1.2 years
November 20, 2009
December 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
They are the cutaneous grooves, being Observed the reduction of the number of the lesions monthly.
4 month
Secondary Outcomes (2)
Extension of the groves and the reduction of these expressed in centimetres
4 months
Adverse effects
4 months
Study Arms (1)
A
EXPERIMENTALCicatrix cream
Interventions
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.
Eligibility Criteria
You may qualify if:
- Signed informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Catalysis SLlead
Study Sites (1)
Pediatric Hospital Juan Manuel Marquez
Havana, La Habana, 10400, Cuba
Study Officials
- PRINCIPAL INVESTIGATOR
Fernanda Pastrana, MD
Pediatric Hospital Juan Manuel Marquez
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 20, 2009
First Posted
November 23, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
December 8, 2010
Record last verified: 2010-12