NCT01018589

Brief Summary

The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of epidermic burns or post surgical scars. The duration of this phase 2 clinical trial will be two months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 8, 2010

Status Verified

December 1, 2010

Enrollment Period

1.2 years

First QC Date

November 20, 2009

Last Update Submit

December 7, 2010

Conditions

Post Surgical ScarsEpidermic Burn

Keywords

Post surgical scarsEpidermic burnCicatrix cream

Outcome Measures

Primary Outcomes (1)

  • Reduction of the areas of lesions at 2 months (end of the treatment)

    2 months

Secondary Outcomes (2)

  • Coloration of the lesions at 2 months (end of the treatment)

    2 months

  • Adverse effects

    2 months

Study Arms (1)

A

EXPERIMENTAL

Cicatrix cream

Other: Cicatrix cream

Interventions

Cicatrix creamOTHER

We will be carried out the topical application of the product (Cicatrix cream) in the epidermic burns or post surgical scars by administration fo the patients twice a day during two months to a dose of 0,1 ml of cream for each cm of surface, being controlled by the specialist in biweekly consultations. To the patient will be explained the technique of the application.

A

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient with lesions characteristic of the investigated illness.
  • 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
  • Family responsible not very cooperative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan Manuel Marquez Pediatric Hospital

Havana, La Habana, 10400, Cuba

Location

Study Officials

  • Edelisa Moredo Romo, MD

    Juan Manuel Marquez Pediatric Hospital

    PRINCIPAL INVESTIGATOR

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

Locations

CU(1)