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Anogenital Wart Burden and Cost of Illnesses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00749294
First Posted: September 9, 2008
Last Update Posted: August 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahidol University
  Purpose
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.

Condition
Warts

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Anogenital Wart Burden, and Cost of Illnesses in Bangkok

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Estimated Enrollment: 150
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation

Detailed 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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting with anogenital warts, conducted at Rajavithi General Hospital and Bangrak Hospital
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749294


Locations
Thailand
Clinical Infectious Diseases Research Unit
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Prof. Punnee Pitisuttithum, M.B.,B.S. Mahidol University
  More Information

Responsible Party: Prof. Punnee Pitisuttithum, Mahidol University
ClinicalTrials.gov Identifier: NCT00749294     History of Changes
Other Study ID Numbers: THALS1570
First Submitted: September 8, 2008
First Posted: September 9, 2008
Last Update Posted: August 9, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases