Efficacy of the Glicigen – Viusid in the treatment of external genitals anus wart in children

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000097
• Date of registration: 04/09/2010
• Primary sponsor: Catálysis S.L.
• Public title: Efficacy of the Glicigen – Viusid in the treatment of external genitals anus wart in children
• Scientific title: CLINICAL TRIAL PHASE III "Efficacy of the Glicigen – Viusid in the treatment of external genitals anus wart in children"
• Date of first enrolment: 06/09/2010
• Target sample size: 76 patients
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000097-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Edelisa Moredo
• Affiliation: Juan Manuel Márquez Pediatric Educational Hospital

• Name: Edelisa Moredo
• Affiliation: Juan Manuel Márquez Pediatric Educational Hospital

Key inclusion & exclusion criteria

Inclusion criteria: Patient with lesions characteristic and diagnostic of (externalanus genitals warts) To be included beetwen 6 and 18 years old of both sexes.(Identify Card) Signed informed consent Negative VDRL, Hepatitis B Antigen and HIV diagnostic test
Exclusion criteria: With previous treatment Pregnant Patients taking steroides, inmunomodulates and topic and sistemic antivirals therapy Patient that refer manifestations of high sensibility to the medication

Age minimum: 6 years
Age maximum: 18 years
Gender: Both

Health Condition(s) or Problem(s) studied

external anus genitals wart

Intervention(s)

Group A: Glicigen+Viusid Glicigen: For 3 to 5 daily application (dependent of the lesion skin size) beetewn 5 days to 8 weeks according to the clinical evolution. There will be topical application (spray). Viusid (sachet): Doses of 4 grams dissolved in 6 ounces of liquid in patients from 6 to 12 years old every 12 hours for 2 months, and in patients from 13 to 18 years old, every 8 hours, for 2 months. Should be taken after meals dissolved in drinking water, milk or fruit juice Group B: Placebo Placebo de Glicigen. Idem to Glicigen group Placebo de Viusid. Idem to Viusid group

Primary Outcome(s)

Disappearance of the lesions (Excellent, Good, Regular, Bad). Measurement time: 2, 4, 6,and 8 weeks after treatment. Excellent (E): Disappearance of the lesions in less than 2 Weeks of initiated the treatment Good (B): Disappearance of the lesions between 2 and 5 weeks of initiated the treatment Regular (R): Disappearance of the lesions between 6 and 8 weeks of initiated the treatment Bad (M) Not Disappearance of the lesions after 8 weeks of treatment.

Secondary Outcome(s)

Reduction of the number of the lesions (Excellent, Good, Regular, Bad).Measurement time: 8 weeks after treatment. Excellent (E) Disappearance of the lesions or reduction equal or more than 75 % Good (B) Reduction between 50 % and less than 75% Regular (R): Reduction less than less than 50 % and more than 25% Bad (M): Reduction equal or less than 25% Appearance of the lesion (flats, papilomatouse): (Good, Regular, Bad). Measurement time: 8 weeks after treatment. Good. Disappearance of the lesion Regular: Changes the appearance from papilomatouse to flat Bad: When remains the same appearance or changes to papilomatouse Adverse lesions present during treatment (good, Regular, Bad). Measurement time: 8 weeks after treatment. Good: Not presents adverse lesions during treatment Regular: Presents adverse lesions but, is possible to continue the treatment Bad: Presents adverse lesions and Is not possible to continue the treatment

Source(s) of Monetary Support

Catálysis S.L.

Secondary Sponsor(s)

Not applicable