Cicatrix Cream in Cutaneous Groves | NCT01018212

Studies
Cicatrix Cream in Cutaneous Groves

NCT01018212

Sponsor

Catalysis SL

Status

Completed

Last Update Posted

Dec 8, 2010Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Cutaneous Groves

Interventions

Cicatrix cream

Countries

Cuba

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Nov 20, 2009

First Submission Date that Met QC Criteria

Nov 20, 2009

First Posted Date

Nov 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2010

Last Update Posted Date

Dec 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Cicatrix cream	Other: Cicatrix cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cicatrix cream	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
They are the cutaneous grooves, being Observed the reduction of the number of the lesions monthly.		4 month

Secondary Outcomes

Measure	Description	Time Frame
Extension of the groves and the reduction of these expressed in centimetres		4 months
Adverse effects		4 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fernanda Pastrana, MD	Pediatric Hospital Juan Manuel Marquez	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Hospital Juan Manuel Marquez		Havana	La Habana	10400	Cuba