Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Condylomata Acuminata

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Imiquimod

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

2.5% imiquimod cream applied daily to wart area for up to 8 weeks

3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.

placebo cream applied daily to wart areas for up to 8 weeks

daily topical application for up to 8 weeks

3.75% imiquimod cream

placebo cream

Jason Wu, MD

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.

Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts

Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.

Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit.

Rest period was a temporary interruption of dosing dur to intolerable LSRs.

Numbers of subjects in each treatment group reporting one or more adverse events

Graceway Pharmaceuticals, LLC

Jason Wu, MD / Exective Director, Product Development

The study duration included 5 month enrollment period, up to 28 week of study period, so total duration from first patient enrolled to the last patient completed study was approximately 12 months

2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks

2.5% Imiquimod Cream

3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks

3.75% Imiquimod Cream

Placebo cream applied once daily to wart areas for up to 8 weeks

Placebo

Total

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Robert Babilon, Vice President, Product Development

Adverse Reactions

Local Skin Reactions

Number of Subjects with Rest Period in Treatment

Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.

Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study

Patients with adverse events considered probably related or related to the administration of the product.

Treatment Related Adverse Events

Overall Study

vehicle gel is used as a control group. The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel. Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube. Apply gel on the lesion warts and on the clinical normal skin on the treated area.

SR-T100 contains 1.0% SM. The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel. Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube. Apply gel on the lesion warts and on the clinical normal skin on the treated area.

SR-T100 contains 2.3% SM. The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel. Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube. Apply gel on the lesion warts and on the clinical normal skin on the treated area.

Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing.

Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing.

Total application \<1,500 mg gel per day.

Vehicle gel

SR-T100 gel with 1.0 % SM

SR-T100 gel with 2.3% SM

Kou-Wha Kuo, PhD

Cheng-Yang Chou, M.D.

To evaluate the efficacy of SR-T100 gel by observing total clearance rate of treated baseline EGW(s) on the treated area.

A double-blind, randomized,vehicle-controlled, parallel-group, and dose-ranging study to evaluate the efficacy and safety of SR-T100 gel in patients with EGW(s). The primary efficacy endpoint will be defined as the proportion of patients whose baseline EGW(s) on the treated area achieve total clearance. The efficacy of SR-T100 gel in prevention of new EGW(s) occurrence will be evaluated. Distinct to existing medications for EGWs, SR-T100 gel possesses characteristics of high safety and low LSR causality. SR-T100 gel will be administered on EGW lesion(s) for clearance and on the surrounding clinical normal skin for prevention of new EGW(s) occurrence.

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

A Double-Blind, Vehicle Controlled, Randomized, Phase II Study of SR-T100 Gel on External Genital Warts/Condyloma Acuminate (EGWs)

including PE, vital sign, lab. test, local skin reaction, and adverse event, etc.

G&E Herbal Biotechnology Co., LTD

Neoplasms

Papilloma

GS-9191 ointment (0.01%, 0.03%, or 0.1%) or placebo applied topically to anogenital warts for one or three cycles, each cycle lasting 5 consecutive nights of ointment application followed by 9 nights off-ointment. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.

GS-9191 ointment

GS-9191 ointment (0.3% or 1.0%) or placebo applied topically to anogenital warts for one or three cycles; each cycle consists of dosing occuring over a 5-night period with ointment application on nights 1, 3 and 5 followed by a 9-day off-ointment period. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.

GS-9191

Elsa Mondou, MD

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.

Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Assessment of the Safety, Tolerability, and Activity of GS-9191 Ointment for the Treatment of External Genital and Perianal Warts Caused by Human Papilloma Virus Infection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts	NCT00674739	Genital Warts	Imiquimod 3.75% imiquimod... placebo cream	12 Years -	Graceway Pharmaceuticals, LLC
Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts	NCT00674739	Genital Warts	Imiquimod 3.75% imiquimod... placebo cream	12 Years -	Graceway Pharmaceuticals, LLC
Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs)	NCT01796821	Condyloma Acumi... Genital Warts Condylomata Acu... Venereal Warts	Vehicle gel SR-T100 gel wit... SR-T100 gel wit...	20 Years -	G&E Herbal Biotechnology Co., LTD
Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts	NCT00499967	Genital Warts	GS-9191 ointmen... GS-9191 Placebo	18 Years - 50 Years	Gilead Sciences

Spots Global Cancer Trial Database for venereal warts