This study will investigate whether injecting genital warts with small quantities of the Gardasil 9 vaccine has an effect on the warts.
This is a prospective, open-label, proof-of-concept research study to assess the effectiveness of intralesional nonavalent in the treatment of patients with genital condylomata. The study will be conducted at Zuckerberg San Francisco General Hospital. The planned intervention is to provide 10 subjects with at least 3 genital condylomata with intralesional nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for change in wart size and wart number.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Change in Wart Number
Change in number of warts in genital area.
Time frame: Baseline (week 0) and Week 12.
Change in Average Size of Genital Warts in mm
Mean size of warts in genital area, as measured by study personnel at study visits .
Time frame: to be measured at baseline (week 0) and Week 12
Change in Score of Specific Questionnaire for Condylomata Acuminata (CECA)
Established tool to measure quality of life with respect to condyloma. Will be administered at baseline and week 12 by study personnel. It comprises 10 items and 2 dimensions. The emotional dimension includes 6 items and the sexual activity dimension includes 4 items. The questions refer to the past 7 days. The higher the score the better the quality of life. The global scoring range was 10-50, ranging from 6 to 30 in the emotional dimensions and from 4 to 20 in the sexual activity dimension.
Time frame: to be measured at baseline (week 0) and week 12
Change in Score of Dermatology Quality of Life Index (DLQI)
Established tool to measure quality of life with any dermatologic disease. Will be administered at baseline and week 12 by study personnel. Consists of 10 questions scored from 0-3. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time frame: to be measured at baseline (week 0) and week 12
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