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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
Primary sponsor:
Catalysis SL
Secondary sponsor:
none
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
Country:
Not entered
Zip Code:
Not entered
Email address:
email@not.entered
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:
2
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
Country:
Cuba
Zip Code:
10400
Telephone:
2609651
Email :
edelisa.moredo@infomed.sld.cu
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
Country:
Cuba
Zip Code:
10400
Telephone:
2609651
Email :
edelisa.moredo@infomed.sld.cu
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
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