Cicatrix Cream in post surgical scarps and epidermic burn

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Clinical trial phase II Efficacy of the Cicatrix Cream in the treatment of post surgical scarps and epidermic burn

Secondary indentifying numbers:

CAT-0904-CU

Issuing authority of the secondary identifying numbers:

Catalysis SL

Source(s) of monetary or material support:

Catalysis SL

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Dra. Edelisa Moredo Romo

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not proceed

Research ethics committees:

Pediatric Hospital "Juan Manuel Márquez", June 8, 2009 (#0904)

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

09/09/2009

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Post surgical scarps and epidermis burn

Intervention(s):

There will be topical application of the product (Cicatrix cream) 2 times daily for 2 months. The dose will be 0,1 ml per centimetre of surface because the product will apply locally in the form of a thin film covering the entire area of the lesions

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Cutaneous grooves (Excellent (E): Disappearance of the lesions to the 2 months of initiate the treatment, Good (B): marked attenuation of the lesions, diminishing their evidence 50%, Regular (R): moderate Decrease of the lesions diminishing their evidence les 50%, Bad (M): That stays the clinical square without variation). Measurement time: 2 months.

Key secondary outcomes:

Color of the lesions (Attenuation of the color of the lesions (Good: if there is marked attenuation of color, Regular: Discrete attenuation of the color, Bad: if patient keeps the original color). Measurement time: 2 months. Security depends of the Adverse Events (AE)(Good: without AE, Regular: There are AE but it is possible to continue the treatment, Bad: Interruption of the treatment due AE). Measurement time: 2 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

newborn

Maximum age:

18 years

Inclusion criteria:

Patient with lesions characteristic of the investigated illness Patients who are between newborn and 18 years old of both sexes (ID card) Signed the 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

Type of population:

Children

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

100 patients

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Edelisa

Last Name:

Moredo Romo

Affiliation:

Pediatric Hospital "Juan Manuel Marquez"

Postal Address:

31 Ave and 76 street Marianao

City:

Havana City

País:

Cuba

Zip Code:

10400

Telephone:

2609651

Email :

edelisa.moredo@infomed.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Edelisa

Last Name:

Moredo Romo

Affiliation:

Pediatric Hospital "Juan Manuel Marquez"

Postal Address:

31 Ave and 76 street Marianao

City:

Havana City

País:

Cuba

Zip Code:

10400

Telephone:

2609651

Email :

edelisa.moredo@infomed.sld.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000091

Date of Registration in Primary Registry:

2009-10-23

Record Verification Date:

2009-09-25 20:00

Link to the spanish version:

Click here [3]