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

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

Source(s) of monetary or material support:

Catálysis S.L.

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

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 aplicable

Research ethics committees:

Pediatric Educational Hospital “Juan Manuel Márquez”, June 1st, 2009 (#0904). Renewed approval May 18, 2010

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

06/09/2010

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:

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

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):

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.

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

6 years

Maximum age:

18 years

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

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:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

76 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

Affiliation:

Juan Manuel Márquez Pediatric Educational Hospital

Postal Address:

31st. Ave and 76th street Marianao

City:

Havana City

País:

Cuba

Zip Code:

10400

Telephone:

2609651

Email :

edelisa.moredo@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:

Edelisa

Last Name:

Moredo

Affiliation:

Juan Manuel Márquez Pediatric Educational Hospital

Postal Address:

31st. Ave and 76th street Marianao

City:

Havana City

País:

Cuba

Zip Code:

10400

Telephone:

2609651

Email :

edelisa.moredo@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:

RPCEC00000097

Date of Registration in Primary Registry:

2010-09-04

Record Verification Date:

2010-09-03 20:00

Link to the spanish version:

Click here [3]