Cicatrix Cream in cutaneous striae

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000090
• Date of registration: 23/10/2009
• Primary sponsor: Catalysis SL
• Public title: Cicatrix Cream in cutaneous striae
• Scientific title: Clinical trial phase II Efficacy of the Cicatrix Cream in the treatment of cutaneous striae
• Date of first enrolment: 09/09/2009
• Target sample size: 50 patients
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000090-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Fernanda Pastrana
• Affiliation: Pediatric Hospital "Juan Manuel Marquez"

• Name: Fernanda Pastrana
• Affiliation: Pediatric Hospital "Juan Manuel Marquez"

Key inclusion & exclusion criteria

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

Age minimum: 10 years
Age maximum: 18 years
Gender: Both

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

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.

Secondary Outcome(s)

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.

Secondary ID(s)

CAT-0902-CU

Source(s) of Monetary Support

Catalysis SL