20 Clinical Trials for Various Conditions
This prospective, multicenter, single-blinded, randomized comparison study is designed to compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of cutaneous non-genital common warts on all areas of the body excluding the scalp, nose, within the orbital region of the face, plantar or periungual area in healthy adult subjects.
Warts, Warts Hand, Verruca
This prospective, non-randomized, multicenter pivotal study is designed to evaluate the safety and effectiveness of the CellFX System in patients with cutaneous non-genital warts on all areas of the body, excluding the face.
Warts, Warts Hand, Verruca
This is a Phase 2, double-blind, placebo-controlled study to determine the dose regimen, safety, tolerability, and efficacy of VP-102 in subjects with External Genital Warts (EGW). This study is divided into two parts (Part A and Part B). Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups prior to progressing to enrollment in Part B. Part A \& B will enroll a approximately 108 subjects completing 4 treatment applications every 21 days and continuing with follow-up assessments at Day 84, 112 and 147.
Condylomata Acuminata, Papillomavirus Infections, Skin Diseases, Viral, Skin Diseases, Infectious, Skin Diseases, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Warts
This 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.
Condylomata Acuminata
The 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.
External Genital Warts
External Genital Warts (EGW) are the most common sexually transmitted disease associated with more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective method of EGW treatment. However, multiple sessions may be required with reported clearance rates ranging between 27-88%. Sinecatechins 15% ointment is Food and Drug Administration approved for three times daily application in immunocompetent subjects 18 years and older for the treatment of EGW and perianal warts. Treatment of EGW with cryotherapy followed by sinecatechins appears to be logical. Cryotherapy has direct cytodestructive effects with immediate short-term efficacy on treated EGW, while sinecatechins provide field therapy, treating both clinical and sub-clinical lesions. For this study, the investigators used sinecatechins 15% ointment twice daily regimen and anticipated that the synergistic effect with cryotherapy will provide better efficacy that cryotherapy alone. The investigators also anticipated that the sequential therapy with be safe.
External Genital Warts
The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams. External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.
Genital Warts
The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams. External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.
Genital Warts
The purpose of this study is to assess the safety, tolerability and activity of GS-9191 ointment in the treatment of genital warts. GS-9191 ointment is intended for topical application directly to genital warts on the skin.
Genital Warts
The 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.
Condylomata Acuminata
A clinical endpoint bioequivalence (BE) study for a Podofilox Gel 0.5% formulation for the treatment of external anogenital warts in comparison to Condylox® Gel 0.5% that follows the study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations
External Anogenital Warts
To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for condyloma acuminatum in patients with HIV infection. To investigate whether topical HPMPC therapy can induce regression of condyloma acuminatum in patients with HIV infection.
HIV Infections, Condyloma Acuminata
A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External Genital Warts and Perianal Warts
Genital Warts, Perianal Warts
Caused by the human papillomavirus (HPV), anogenital warts are a common sexually-transmitted infection (STI). They are distressing to those who have them and are a source of viral shedding and transmission to others. Treatment of warts is aimed at destruction of the lesion. Objectives: 1. Establish safety of Multikine in treatment of perianal condyloma. 2. Describe presence of anal HPV and anal dysplasia in participants with perianal condyloma. 3. Describe adverse effects associated with Multikine in the management of perianal condyloma. Design: Phase I, dose-escalation trial. Potential participants desiring treatment for their perianal warts will be referred to study by their primary clinician. All participants will undergo baseline anal Pap, anal HPV subtyping, perianal condyloma characterization (count, measurement, photography), and complete a baseline questionnaire. Cohort A participants will undergo perilesional Multikine injections (200IU) once daily, Monday through Friday, for 14 days, off for 14 days, then again once daily, Monday through Friday for 14 days. If no serious adverse events are noted after 4 weeks of therapy, cohort B will be studied using the same schedule but with a dose of 400IU per treatment. Each participant will undergo anal Pap and anal HPV subtyping once weekly during treatment. Condyloma characterization (count, measurement, photography) will occur prior to each treatment. After treatment completed, participants will complete a follow-up visit at 70, 100, 130, 160 days and have anal Pap, anal HPV subtyping, and perianal condyloma characterization (count, measurement, photography) performed. Subjects: The study will be open to adult men and women who are HIV-infected who receive medical care from the Naval Medical Center San Diego. Main Outcome Measures: 1. Perianal wart characterization \[count, measurement (in millimeters diameter)\], photography) 2. HPV subtype in anal canal 3. Anal dysplasia cytologic grade 4. Questionnaire responses 5. Adverse effects experienced during treatment, recorded in symptom log
Condyloma
This study will investigate whether injecting genital warts with small quantities of the Gardasil 9 vaccine has an effect on the warts.
Human Papilloma Virus, Warts, Warts, Genital, Condyloma, Condylomata Acuminata
Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses of HPV vaccine for eligible male and female adolescents who have initiated vaccination.
Human Papilloma Virus Infection Type 11, Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Human Papilloma Virus Infection Type 6, Cervical Cancer, Genital Warts, Oropharyngeal Cancer
The purpose of this study was to determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls elicited an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing schedule. This was a prospective observational study of healthy 9-18 year old female patients receiving either a second or third dose of HPV vaccine as part of their well child care. Immune responses to HPV types 6, 11, 16 and 18 were measured both before and 1 month after the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV vaccine when administered at naturally occurring longer dosing intervals to the immune response to HPV vaccine when administered as routinely recommended. In addition, girls receiving a 3rd dose of HPV vaccine as well as concomitantly administered vaccines by injection were randomized to receive either the HPV vaccine first or their concomitantly administered vaccines first. Pain following vaccination was assessed in each arm using the Faces Pain Scale - Revised. Please note: This record refers only to the observational portion of the study. Please refer to NCT00862810 for the results of the randomized portion of the study.
Cervical Cancer, Genital Warts
To determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls elicits an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing schedule. This is a prospective observational study of healthy 9-18 year old female patients receiving either a second or third dose of HPV vaccine as part of their well child care. Immune responses to HPV types 6, 11, 16 and 18 will be measured both before and 1 month after the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV vaccine when administered at naturally occurring longer dosing intervals to the immune response to HPV vaccine when administered as routinely recommended. Girls receiving a 3rd dose of HPV vaccine in addition to concomitantly administered vaccines by injection were randomized to receive either the HPV vaccine first or their concomitantly administered vaccines first. Pain following vaccination was assessed in each arm using the Faces Pain Scale - Revised. Please note: This record refers only to the randomized portion of the study where pain following vaccination was assessed. Please refer to NCT02280642 for the observational portion of the study.
Cervical Cancer, Genital Warts
The perianal region is the region around the anus. Administering a pain medication before a surgery starts is called preemptive analgesia. In some studies, this technique has been shown to be an effective way to reduce the pain that a patient experiences in the post-operative timeframe to a greater extent than would be expected simply from the pain medications alone. One theory of why this occurs suggests that the preemptive analgesia desensitizes brain and nerves to pain, thereby decreasing the response to painful stimuli, like surgery when they occur. This leads to a decrease in the amount of narcotic pain medication required after the procedure, which leads to less side effects and a quicker return to normal functioning. As perianal surgeries do not usually include a long stay in the hospital, controlling post-procedure pain is a priority. The use of preemptive analgesia is in other types of surgeries, such as orthopedics, is well established, but as the perianal region has not been well studied, its use is not the standard of care. This type of analgesia uses a combination of medications that are already in use for post-operative and non-operative pain control and administers them orally prior to the patient undergoing general anesthesia. The side effects of the medications are the same as if they had been given after surgery or for non-surgical pain. The concept of preemptive analgesia is established in other types of surgeries and it has solid basic science to support its use. The purpose of this randomized, double-blind, placebo controlled study is to determine if patients undergoing perianal surgeries could benefit from preemptive pain control. The primary outcome will be whether patients experience less post-operative pain. Patient post-operative consumption and latency until use of narcotic pain medication will be the secondary outcomes. The investigators believe that the patients receiving pain medications before their operation will require less pain medication after surgery, with minimal increased risk to the patient.
Hemorrhoids, Fissure in Ano, Rectal Fistula, Anal Condyloma
This study is designed to identify barriers that prevent men who have sex with men from receiving doctor-recommended annual follow-up screenings for anal cancer. Men who are at the highest risk for developing anal cancer will be asked to complete a brief questionnaire (either via telephone or in writing). The questionnaire is designed to identify potential barriers to care-seeking behavior including, relationship status, financial constraints, highest level of education and knowledge about anal cancer and its precursors. The men who agree to participate in the study will then be organized into groups based on their history of coming in for follow-up screening visits after learning that they are at higher risk for developing anal cancer. These groups include 1) men that have come in for regular screening visits (at least once per year), 2) men who came in once and were then lost to follow-up, 3) men who came in for more than one screening visit and were then lost to follow-up, and 4) men who were previously lost to follow-up and then began coming in for screening again. By comparing the men's responses across the different groups, we hope to uncover key barriers and drivers to follow-up screenings for anal cancer. The goal of this study is to evaluate the differences in questionnaire responses across cohorts that may impact care-seeking behavior. We hypothesize that: * Patients who regularly comply with annual follow-up screening visits score higher on questions assessing knowledge of HPV and anal cancer. * Men in stable relationships are more likely to comply with annual screening visit recommendations. * Men who are educated by their primary care physicians about the importance of anal cancer screenings have higher screening rates.
Anal Cancer