Genital Warts

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Genital Warts

General Purpose:

Genital warts are a type of sexually transmitted infection (STI, or “STD”) that can arise anywhere on the male or female genitalia. They are caused a number of viruses in the human papilloma virus (HPV) family; although, not all HPV viruses lead to the development of genital warts. Interestingly, HPV infection on and around the genitals is relatively common, however most people never experience any symptoms.

HPV is transmitted between individuals during sexual contact, and warts can be spread even if they are not visible on the infected person. Warts also may not appear for as long as six months following infection. In some instances, it may be years before they are noticeable.

Individuals who have multiple sex partners, those who are sexually active at a young age, those who use alcohol and tobacco, and pregnant women are more likely to get genital warts. They may also spread them more quickly than other individuals.

In addition, individuals who are infected with the herpes virus and who are under considerable stress, as well as those who have a weak immune system, are also at an increased risk of infection.

Treatment is always required, and it is important to note that over-the-counter wart treatments are not intended for use in treating genital warts. Treatment must be received by a doctor.

Such treatments may include skin treatments as well as prescription medication. Surgery may also be used. It is also important to note that some types of HPV can cause cancer of the cervix and vulva in women; in fact, HPV is the leading cause of cervical cancer.

In recent years, HPV awareness has increased following development of vaccines developed to protect against diseases caused by several HPV strains, including HPV6, HPV11, HPV16 and HPV18. These are the HPV viruses that cause most cases of genital warts and cervical cancers.

These vaccines are the result of years of research into HPV, research which continues today. Both the federal government and numerous academic institutions are hard at work conducting research to better understand how HPV behaves in the body, develop better methods of diagnosing an HPV infection, and investigating the effectiveness of new prevention strategies.

What Will Genital Wart Clinical Trials Be Like?

The types of procedures used in genital wart clinical trials will ultimately depend on the specific nature of the study and what aspect of HPV or genital warts is being studied. Provided below is a list of common procedures, tests, and assessments that may be incorporated into such clinical trials:

  • Detailed physical examination
  • Pelvic exam (for women)
  • Pap smear / Pap test to obtain a sample of cervical cells to test for the presence and type of HPV.
  • You may be required to take an oral medication, use a topical gel or lotion applied to your genital warts, or undergo a surgical or skin therapy procedure.
  • Questionnaires to evaluate your stress level and/or emotional well-being
  • Questionnaires to document your sexual history, including the age at which you first became sexually active, number of current and lifetime sexual partners, and the types of sexual activities in which you engage.
  • Blood tests
  • Biopsy
  • Photographs of your warts

Typical Genital Wart Clinical Trial Protocol:

Specific examples of clinical trials for genital warts might include the following:

  • A randomized trial comparing two different concentrations of a new prescription cream for the treatment of genital warts caused by HPV6 and HPV11. This trial would randomly assign patients to receive treatment with either polyphenon 10%, polyphenon 15%, or a placebo cream. Patients would be required to apply the cream to their visible warts twice a day over a 16 week period. At the conclusion of the study, the three groups would be compared to determine which concentration of the cream was most effective at treating participants’ warts while producing the fewest number of side effects.  
  • A study to determine if two different dosing schedules for an HPV vaccine create equal immunity within a population of girls between the ages of 10 and 18.
  • A clinical trial in which patients with genital warts use a newly-developed topical medication three times a day for seven days, and provide blood samples at three time points throughout the study for analysis of certain chemicals. Patients’ blood samples would be compared to those provided by a group of healthy volunteers who consumed a specific dietary supplement three times a day for seven days.
  • An observational study that administers questionnaires to 300 men between the ages of 16 and 20 who report having an active sex life that includes having sex with other men. The questionnaires would obtain information regarding sociodemographic information, recent and lifetime sexual experiences, history of sexually transmitted infections, knowledge regarding HPV infection, and behavioral characteristics (including drug and alcohol use). The purpose of this study would be to determine the prevalence of HPV infection, and to predict which lifestyle and sexual behaviors are most associated with infection, in this group of men.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated (such as the first clinical trial example described above), the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials.  Examples of information you may want to have on hand include the following:

  • Your history of infection with HPV
  • The type of HPV infection you have (HPV6, HPV18, etc.) (if known)
  • Your prior and current diagnoses of any other health conditions or diseases
  • Your current medications (including vitamins, minerals, and other dietary supplements)

Suggested Search Terms:

 “genital warts treatment,” “genital warts prevention,” “genital warts men,” “genital warts women,” “genital warts adolescents,” “genital warts vaccine,” “genital warts surgery,” “genital warts children,” “genital warts pregnancy,” and “genital warts sexual activity.”

Current Search Term:

“Genital Warts”

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Efficacy of Quadrivalent HPV Vaccine to Prevent Relapses of Genital Warts After Initial Therapeutic Response

Condition:   Genital Warts
Interventions:   Biological: Vaccination with Gardasil;   Biological: Injection of Normal Saline
Sponsor:   Assistance Publique - Hôpitaux de Paris

Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial

Conditions:   Anogenital Human Papillomavirus Infection;   Condyloma Anal
Interventions:   Drug: Imiquimod 5% cream;   Drug: Placebo cream;   Procedure: Fulguration
Sponsor:   Medical University Innsbruck
Not yet recruiting

Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)

Conditions:   Anal Carcinoma;   Anal Condyloma
Intervention:   Diagnostic Test: Search of anal citology alterations
Sponsor:   Universidade do Vale do Sapucai

A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of External Genital Warts

Condition:   Condylomata Acuminata
Intervention:   Drug: VIR007
Sponsors:   ViroXis Corporation;   Progressive Clinical Research

Safety and Efficacy of Immune Therapy for Condyloma

Condition:   Condylomata Acuminata
Intervention:   Biological: DC-CIK immunotherapy
Sponsor:   Shenzhen Second People's Hospital

Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients

Condition:   Genital Wart
Interventions:   Biological: tuberculin;   Device: cryotherapy
Sponsor:   Assiut University
Not yet recruiting

Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)

Conditions:   Cervical Cancer;   Vulvar Cancer;   Vaginal Cancer;   Genital Warts;   Human Papillomavirus Infection
Intervention:   Biological: V503
Sponsor:   Merck Sharp & Dohme Corp.
Active, not recruiting

Assessment of the Predictive Value of the Acetic Acid Test in Surgery Condition for the Detection of Dysplastic Lesions in Patients With Anal Condylomatosis

Condition:   Anal Condyloma
Intervention:   Procedure: acetic acid test
Sponsor:   Hospices Civils de Lyon

Ano-genital Human Papillomavirus (HPV) Infection, Precancerous Lesions and Genital Warts Among Danish Renal Transplant Recipients

Condition:   Anogenital Dysplasia
Sponsors:   Bispebjerg Hospital;   Danish Cancer Society

Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts

Condition:   Condylomata Acuminata (External)
Interventions:   Drug: Omiganan (CLS001) topical gel;   Drug: Vehicle topical gel
Sponsors:   Cutanea Life Sciences, Inc.;   Leiden University Medical Center

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical Applications of AP611074 5% Gel for up to 16 Weeks in Condyloma Patients

Condition:   Condyloma
Interventions:   Drug: AP611074 5% gel;   Drug: AP611074 matching placebo
Sponsor:   Anaconda Pharma

Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)

Conditions:   Cervical Cancer;   Vulvar Cancer;   Vaginal Cancer;   Genital Warts;   Human Papillomavirus Infection
Interventions:   Biological: V503;   Biological: GARDASIL
Sponsor:   Merck Sharp & Dohme Corp.
Active, not recruiting

Safety and Tolerability Study of V501 in Japanese Boys (V501-200)

Conditions:   Anogenital Human Papilloma Virus Infection;   Condyloma Acuminata
Intervention:   Biological: V501
Sponsor:   Merck Sharp & Dohme Corp.
Active, not recruiting

Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)

Conditions:   Condylomata Acuminata;   Papillomavirus Infections;   Sexually Transmitted Diseases
Interventions:   Drug: Ranpirnase;   Drug: Vehicle
Sponsor:   Tamir Biotechnology, Inc.

Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

Condition:   Condylomata Acuminata
Interventions:   Device: Carbon dioxide Laser ablation;   Device: Electrocoagulation
Sponsors:   Zydolab - Institute of Cytology and Immune Cytochemistry;   Ruhr University of Bochum

Efficacy and Tolerability of Topical LFX453 for External Genital Warts

Condition:   External Genital Warts
Interventions:   Drug: Investigational Treatment;   Drug: Aldara
Sponsor:   Novartis Pharmaceuticals

Topical NVN1000 for the Treatment of External Genital and Perianal Warts

Conditions:   Genital Warts;   Perianal Warts
Interventions:   Drug: NVN1000;   Other: Vehicle Gel
Sponsors:   Novan, Inc.;   PPD

Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts

Condition:   Anogenital Warts
Intervention:   Drug: Picato
Sponsor:   LEO Pharma

A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts

Conditions:   Anogenital Warts;   Condylomata Acuminata
Interventions:   Drug: Topical NO;   Drug: Placebo
Sponsors:   University of Aberdeen;   Prostrakan Pharmaceuticals;   Erasmus Medical Center

Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)

Conditions:   Anogenital Human Papilloma Virus Infection;   Condyloma Acuminata
Interventions:   Biological: V501;   Biological: Placebo
Sponsor:   Merck Sharp & Dohme Corp.

Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs)

Conditions:   Condyloma Acuminata;   Genital Warts;   Condylomata Acuminata;   Venereal Warts
Interventions:   Drug: Vehicle gel;   Drug: SR-T100 gel with 1.0 % SM;   Drug: SR-T100 gel with 2.3% SM
Sponsor:   G&E Herbal Biotechnology Co., LTD
Active, not recruiting

Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

Conditions:   Genital Warts;   Anal Cancer;   Anal Intraepithelial Neoplasia
Intervention:   Biological: 9vHPV Vaccine
Sponsor:   Merck Sharp & Dohme Corp.

A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

Conditions:   Cervical Cancers;   Vulvar Cancers;   Vaginal Cancers;   Genital Warts
Interventions:   Biological: V503;   Biological: Placebo to V503
Sponsor:   Merck Sharp & Dohme Corp.

Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil)(V501-015)

Conditions:   Cervical Cancer;   Genital Warts
Interventions:   Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine;   Biological: Matching Placebo
Sponsor:   Merck Sharp & Dohme Corp.

An Investigational Study of Gardasil™ (qHPV, V501) Vaccine in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

Condition:   Condylomata Acuminata
Interventions:   Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine;   Biological: Comparator: placebo (unspecified)
Sponsor:   Merck Sharp & Dohme Corp.

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