A Phase 2, Randomized, Double-Blinded, Vehicle-Controlled, Multicenter Study of Topical AS101 for External Genital Warts

A study of AS101 versus placebo in subjects with external genital warts to evaluate effectiveness and safety.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000580471

Enrollment

140

Registered

2007-11-09

Start date

2008-01-07

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will evaluate the safety (i.e. incidence and type of adverse events) and efficacy (i.e. as measured by complete clearance) of AS101 administered twice daily topically over a treatment period of up to 16 weeks, or until complete clearance of external genital warts in the treatment area.

Interventions

Patients will be assigned to one of four treatment groups: 1. AS101 15% ointment twice a day. 2. AS101 15% once a day and placebo ointment once a day. 3. AS101 5% ointment twice a day. 4. Placebo ointment twice a day. Ointment to be applied for up to 16 weeks, or until complete clearance of external genital warts in the treatment area.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Men and women 18 years of age or older and in good health; Clinical diagnosis of external genital warts, in the external genitalia including penis, scrotum, vulva (labia minora and majora), inguinal folds, pubic area, perineum, perianal, or buttocks areas; A minimum of two (2) warts and a maximum of 50 warts in the Treatment Area; A maximum Treatment Area (product of maximum perpendicular dimensions) of < 1000 mm2;

Exclusion criteria

Topical or systemic immunosuppressive or immunomodulatory medications (including corticosteroids) within 30 days of Day 1, and while on study; Any treatment for genital warts within 14 days of Day 1, and patients must have completely recovered from skin irritation and other clinical signs or symptoms associated with the prior therapy; Current active infection with herpes genitalis or history of herpes genitalis infection within the last 30 days of Day 1 (patients on long-term suppressive antiviral therapy are eligible); Known history of human immunodeficiency virus (HIV) infection; Known current acute or chronic infection with hepatitis B or C virus (HBV or HCV); Cutaneous surgery, including cryosurgery, to genital area within 30 days of Day 1;

Outcome results