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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A Trial of a New Botanical Drug For the Treatment of External Condylomata Acuminata in Adult Subjects

Condition:   Condylomata Acuminata
Intervention:   Drug: VIR007
Sponsor:   ViroXis Corporation
Not yet recruiting - verified May 2017

Safety and Efficacy of Immune Therapy for Condyloma

Condition:   Condylomata Acuminata
Intervention:   Biological: DC-CIK immunotherapy
Sponsor:   Shenzhen Second People's Hospital
Not yet recruiting - verified March 2017

Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients

Condition:   Genital Wart
Interventions:   Biological: tuberculin;   Device: cryotherapy
Sponsor:   Assiut University
Not yet recruiting - verified May 2017

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
Recruiting - verified April 2017

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
Recruiting - verified January 2017

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
Completed - verified March 2017

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
Recruiting - verified May 2017

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.
Completed - verified March 2017

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
Recruiting - verified October 2016

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
Active, not recruiting - verified January 2017

Efficacy and Tolerability of Topical LFX453 for External Genital Warts

Condition:   External Genital Warts
Interventions:   Drug: LFX453;   Drug: Aldara®
Sponsor:   Novartis Pharmaceuticals
Completed - verified May 2017

Safety and Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine

Condition:   Condylomata Acuminata
Interventions:   Biological: low dosage HPV Vaccine;   Biological: medium dosage HPV Vaccine;   Biological: high dosage HPV Vaccine;   Biological: Aluminium Adjuvant
Sponsors:   Jun Zhang;   Xiamen Innovax Biotech Co., Ltd;   Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Active, not recruiting - verified December 2015

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
Completed - verified May 2017

The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases

Conditions:   Human Papillomavirus Infection;   Genital Warts
Sponsors:   Jun Zhang;   Liuzhou center of disease prevention and control
Completed - verified July 2014

Safety and Efficacy Double Blind Vehicle Controlled Study of 15% AS101 Gel to Treat External Genital Warts

Condition:   External Genital Warts
Interventions:   Drug: 15% AS101 gel;   Drug: Vehicle
Sponsor:   BioMAS Ltd
Recruiting - verified October 2016

Safety Study of Multikine in the Treatment of Perianal Warts

Condition:   Condyloma
Interventions:   Drug: Leukocyte Interleukin, Injection 200IU;   Drug: Leukocyte Interleukin, injection 400IU
Sponsors:   United States Naval Medical Center, San Diego;   CEL-SCI Corporation
Terminated - verified August 2016

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
Completed - verified December 2013

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.
Completed - verified March 2017

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

Conditions:   Genital Warts;   HPV
Interventions:   Drug: Oral Zinc;   Drug: Placebo
Sponsors:   University of British Columbia;   British Columbia Centre for Disease Control
Terminated - verified October 2016

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.
Completed - verified March 2017

The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata

Conditions:   HIV Positive;   Anal Condylomata;   Anal Warts;   HIV Infections
Interventions:   Drug: Saline;   Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Sponsor:   Washington University School of Medicine
Completed - verified June 2016

Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)

Conditions:   Cervical Cancer;   Genital Warts
Interventions:   Biological: V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years;   Biological: Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years
Sponsor:   Merck Sharp & Dohme Corp.
Completed - verified March 2017

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.
Active, not recruiting - verified January 2017

Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

Conditions:   Cervical Cancer;   Genital Warts
Intervention:   Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years
Sponsor:   Merck Sharp & Dohme Corp.
Completed - verified March 2017

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.
Completed - verified April 2017

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