Cicatrix Cream in post surgical scarps and epidermic burn

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000091
• Date of registration: 23/10/2009
• Primary sponsor: Catalysis SL
• Public title: Cicatrix Cream in post surgical scarps and epidermic burn
• Scientific title: Clinical trial phase II Efficacy of the Cicatrix Cream in the treatment of post surgical scarps and epidermic burn
• Date of first enrolment: 09/09/2009
• Target sample size: 100 patients
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000091-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: Edelisa Moredo Romo
• Affiliation: Pediatric Hospital "Juan Manuel Marquez"

• Name: Edelisa Moredo Romo
• Affiliation: Pediatric Hospital "Juan Manuel Marquez"

Key inclusion & exclusion criteria

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

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

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

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.

Secondary Outcome(s)

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.

Secondary ID(s)

CAT-0904-CU

Source(s) of Monetary Support

Catalysis SL