Not Yet RecruitingPhase 2ACTRN12607000580471

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.

Sponsor

Miramar Therapeutics, Inc, USA

Enrollment

140 participants

Start Date

Jan 7, 2008

Study Type

Interventional

Conditions

External Genital Warts

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is about a Phase 2, Randomized, Double-Blinded, Vehicle-Controlled, Multicenter Study of Topical AS101 for External Genital Warts. It is looking for adults aged 18 and older to participate. To join, participants should meet requirements such as: Men and women 18 years of age or older and in good health;. Participants will be guided through the study procedures by the research team and may need to attend scheduled visits.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.

Locations(1)

New Zealand

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ACTRN12607000580471