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.”

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“Genital Warts”

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Intervention:  
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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
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Topical NVN1000 for the Treatment of External Genital and Perianal Warts


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Efficacy and Tolerability of Topical LFX453 for External Genital Warts


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The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases


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Intervention:  
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Safety Study of Multikine in the Treatment of Perianal Warts


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


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Sponsors:   University of Aberdeen;   Prostrakan Pharmaceuticals;   Erasmus Medical Center
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Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)


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A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts


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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.
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Conditions:   Cervical Cancer;   Genital Warts
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