Cicatrix Cream in cutaneous striae

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 cutaneous striae

Secondary indentifying numbers:

CAT-0902-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. Fernanda M Pastrana Fundora

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 (#0903)

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:

Cutaneous striae

Intervention(s):

There will be topical application of the product (Cicatrix cream) 3 times daily for 4 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):

Evaluation of the striaes (Excellent (E) Disappearance the striaes to the 4 months of initiate the treatment, Good (B): Disappearance of the striaes more than 50 %, Regular (R): Disappearance of the striaes less than 50 %, Bad (M): That stays the clinical square without variation). Measurement time: monthly for 4 months.

Key secondary outcomes:

Extension and reduction of the striaes expressed in centimetres (Good: Reduction of more than 50% in centimeters, Regular: Reduction of less than 50% in centimetres, Bad: No reduction). Measurement time: monthly for 4 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: monthly for 4 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:

10 years

Maximum age:

18 years

Inclusion criteria:

Patient with cutaneous striae Patients aged 10 years and 18 years 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:

50 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:

Fernanda

Middle Name:

Maria

Last Name:

Pastrana

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 :

fpastrana@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:

Fernanda

Middle Name:

Maria

Last Name:

Pastrana

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 :

fpastrana@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:

RPCEC00000090

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]