Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053)
Genital WartsThis study is designed to demonstrate non-inferior immunogenicity of 3 doses of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) in Chinese males 9 through 19 years of age, and 2 doses of the 9vHPV vaccine in Chinese males 9 through 14 years of age, compared to the 3 dose regimen in Chinese males 20 through 26 years of age (from Merck Protocol V503-052). The primary hypothesis is that each of the 3-dose regimen in Chinese males aged 9 through 19 years and 2-dose regimens in Chinese males aged 9 through 14 years induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) at one month post last dose compared to the 3-dose regimen in Chinese adult males aged 20 through 26 years. A noninferiority margin of 0.67 in the GMT ratio (9 through 19 years of age or 9 through 14 years of age vs 20 through 26 years of age) is used for each HPV type.
Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)
WartsGenital2 moreThe purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus [9vHPV] vaccine) in preventing HPV-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo.
Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts
Anogenital WartThis clinical trial aims to assess the efficacy of topical Piper crocatum in treating Anogenital warts. It aims to answer the clinical efficacy of treating anogenital warts the expression of Foxp3+ regulatory T (Treg), TGF/Tumor Growth Factor -β1, and IFN/interferon -γ of anogenital wart lesion Participants will be allocated into two topical treatments, intervention and active comparator Trichloroacetic Acid (TCA) 90%. The researchers assume that intervention is superior compared to TCA 90%
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of External...
Condylomata AcuminataThis trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and efficacy of VIR007 when administered topically for up to 60 days to adults between the ages of 18 to 65 years with a clinical diagnosis of external condylomata acuminata.
Recurrent and Nonrecurrent Condyloma Treatment
Recurrent CondylomaNonrecurrent CondylomaTreatment is considered successful if the difference in the response in the reduction of the affected area is above 30% for any of the doses compared to placebo Patients will be randomised to 1 of 3 treatment arms Placebo CIGB-300 - 5 mg CIGB-300 - 15 mg A two week screening visit will take place to assess patient eligibility, at least 2 to 5 target lesions (area of the lesion between 20 to 80 mm2), should be identified. Patients included in the study will be randomly assigned to one of three study arms. Treatment consists of 3 perilesional applications at the base of the target lesion every 48 hours with a window of ±24hs. After each application the potential local and systemic adverse events will be identified and monitored. After the last application is made, weekly clinical evaluations for 3 weeks and then every two weeks, until week 12 will take place. At this time, clinical assessment of efficacy will be carried out that will define the response to treatment. After this visit, patients will be followed every 3 months until one year after the last treatment has been completed to confirm response and long-term security of the CIGB-300 application. At screening, at 2 and 8 weeks as well as at 6 and 12 months post-treatment blood studies will be conducted to assess the safety from the systemic point of view.
A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital...
Genital WartsHPVThe purpose of this study is to examine the effect of 400 mg of oral zinc gluconate on genital warts. Our hypothesis is that there will be a 10% difference in complete clearance of genital warts in the group randomized to oral plus standard of care compared to those randomized to placebo plus standard of care.
Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)...
Cervical CancerVulvar Cancer3 moreProtocol V503-021 is a long-term follow-up study of the V503-001 base study (NCT00543543) to evaluate the safety, immunogenicity, and long-term effectiveness of V503 vaccine in preventing cervical cancer and related precancers caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58. Because of the high retention of V503-001 participants from the Nordic countries, and the highly efficient screening and surveillance system there, study V503-021 will evaluate only participants from V503-001 sites in Denmark, Norway, and Sweden. The hypothesis being tested is that V503 vaccine will remain effective for at least 14 years after the start of vaccination.
Efficacy and Tolerability of Topical LFX453 for External Genital Warts
External Genital WartsThe LFX453X2202 study tested the investigational drug LFX453 against placebo for safety, tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an additional open label arm using imiquimod 5%. During the study the patients received either LFX453, placebo or active comparator and the tolerability and safety was assessed continuously through local tolerability assessments and adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken for safety, pharmacokinetics (PK), and biomarkers.
Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts
Condylomata AcuminataThe purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients.
The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata
HIV PositiveAnal Condylomata2 moreThe primary objective of this pilot study is to evaluate the effect of the HPV vaccine Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.