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Cicatrix Cream in Cutaneous Groves

NCT ID: NCT01018212

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Cutaneous Groves

Keywords

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Cutaneous Groves

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Cicatrix cream

Group Type EXPERIMENTAL

Cicatrix cream

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catalysis SL

INDUSTRY

Sponsor Role lead

Responsible Party

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Pediatric Hospital Juan Manuel Márquez

Principal Investigators

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Fernanda Pastrana, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Hospital Juan Manuel Marquez

Locations

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Pediatric Hospital Juan Manuel Marquez

Havana, La Habana, Cuba

Site Status

Countries

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Cuba

Other Identifiers

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CAT-0902-CU

Identifier Type: -

Identifier Source: org_study_id