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

Phase 3

• Conditions: external anus genitals wart

• Registration Number: RPCEC00000097
• Lead Sponsor: Catálysis S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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