Anogenital Wart Burden and Cost of Illnesses

Warts Clinical Trial

Official title:

Measurement of Anogenital Wart Burden, and Cost of Illnesses in Bangkok

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749294
• Other study ID #: THALS1570
• Status: Completed
• Phase: N/A
• First received: September 8, 2008
• Last updated: August 6, 2010
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2010
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

The study will be a prospective study of patients presenting with anogenital warts. The objective are to assess proportion of anogenital warts to the total number of sexual transmitted infection patients, to quantify direct and indirect cost of illnesses and psychological burden associated with anogenital warts and to estimate government program expenditure for the prevention and control and treatment of the STI/anogenital HPV infection.

Description:

An observational study, multiple visit, 2-center study will be conducted in Rajavithi General Hospital, and Bangrak Hospital. One hundred and fifty subjects will be enrolled from both hospitals. Anogenital wart patients presented in Rajavithi General Hospital and the STI clinic at Bangrak Hospital will be recruited prospectively. All patients will be treated according to standard medical guidelines or usual care of the institutes. After the baseline assessment, the patients will have follow up visits with their physicians and will also be interviewed at the clinical sites three time approximately at day 7 (-2+7 days), month 1 (+-7 days), and month 6 (+-7 days) until they are cure. At month 6 (+-14 days), telephone assessment for the capture of any signs of disease recurrence will be done. All patients will be followed for 6 months under the same schedule.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is 18 years of age or older and has anogenital warts

• Physician confirmed clinical diagnosis of anogenital warts

• Subject is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent

• Subject will be available for the study follow up period

Exclusion Criteria:

• Subject is unable to give informed consent

• Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives such as other concurrent/active STI

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Warts

Locations

Country	Name	City	State
Thailand	Clinical Infectious Diseases Research Unit	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand,