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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Up to 16 weeks

Safety Issue:

No

Principal Investigator

Jason Wu, MD

Investigator Role:

Study Director

Investigator Affiliation:

Graceway Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

GW01-0801

NCT ID:

NCT00674739

Start Date:

May 2008

Completion Date:

July 2009

Related Keywords:

• Genital Warts
• external genital warts
• perianal warts
• condylomata acuminata
• venereal warts
• HPV types 6 and 11
• Condylomata Acuminata
• Warts