Trial Outcomes & Findings for Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population (NCT NCT01598779)
NCT ID: NCT01598779
Last Updated: 2015-12-21
Results Overview
150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type
Recruitment status
COMPLETED
Target enrollment
150 participants
Primary outcome timeframe
4 months
Results posted on
2015-12-21
Participant Flow
Participant milestones
| Measure |
Patients Having External Genital Warts
Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.
In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the
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|---|---|
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Overall Study
STARTED
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150
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Overall Study
COMPLETED
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150
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population
Baseline characteristics by cohort
| Measure |
Patients Having External Genital Warts
n=150 Participants
Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.
In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the
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|---|---|
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Age, Continuous
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28.48 years
n=93 Participants
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Sex: Female, Male
Female
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150 Participants
n=93 Participants
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Sex: Female, Male
Male
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0 Participants
n=93 Participants
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Region of Enrollment
Argentina
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150 participants
n=93 Participants
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PRIMARY outcome
Timeframe: 4 monthsPopulation: Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, All biopsies were analyzed to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.
150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type
Outcome measures
| Measure |
Women With External Genital Warts
n=150 Participants
Women age 15-45 attending an outpatient consultation at clinics of the investigators or at University of Buenos Aires, with a lesion suspected of being HPV related were eligible to enter in the study. The main manifestations of genital warts include cauliflower-like condylomata acuminata lesions, keratotic and smooth papular warts, subclinical "flat" warts, Patients previously vaccinated with commercially available vaccines (Gardasil™ or Cervarix™) were not invited to participate.
Inclusion criteria: women between 15 and 45 years old, with External Genital Warts. We will exclude women under treatment corticosteroids, having an immunosuppressive disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known
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Human Papillomavirus (HPV) Types in External Genital Warts (EGW)
HPV 6
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80 percentage of participants
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Human Papillomavirus (HPV) Types in External Genital Warts (EGW)
HPV 11
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12.66 percentage of participants
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Human Papillomavirus (HPV) Types in External Genital Warts (EGW)
HPV 6 & 11
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0.66 percentage of participants
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Human Papillomavirus (HPV) Types in External Genital Warts (EGW)
HPV 16
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2 percentage of participants
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Human Papillomavirus (HPV) Types in External Genital Warts (EGW)
HPV 73
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0.66 percentage of participants
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Human Papillomavirus (HPV) Types in External Genital Warts (EGW)
Negative
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4 percentage of participants
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Adverse Events
Patients Having External Genital Warts
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place