NCT02483455

ALC-919 For The Treatment Of Common Warts

ALC-919 For The Treatment Of Common Warts (Verruca Vulgaris)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Veloce BioPharma LLC · Industry
• Sex: All
• Age: 8 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, double blind, vehicle-controlled phase 2 study of subjects 8 years of age and older with Common Warts (Verruca vulgaris) who desire treatment.

Detailed description

This is a single-center, randomized, double blind, vehicle-controlled phase-2 study of subjects 8 years of age and older with Common Warts (Verruca vulgaris) who desire treatment. A total of four visits are planned including one baseline and three follow-ups. Screening will be done at Visit 1 (Baseline) and all safety and efficacy measurements will be made at all subsequent visits (Visits 2-4). The primary objective is to evaluate the efficacy of twice daily-applied ALC-919 vs. vehicle in male and female subjects 8 years of age and older with Common Warts (Verruca vulgaris). The primary outcome measure is complete resolution of lesions at the 12 week visit. Secondary outcome measures will include the change in lesion count at the 12 week visit, improvement in the Global Aesthetic Improvement Scale score at the 12 week visit and the safety and tolerability profile of the treatment arm compared to the vehicle arm at each study visit. The safety will be assessed using clinical cutaneous safety exams that will report scaling, dryness and erythema on a scale of 0-3 (0= absent, 1=mild. 2=moderate, 3=severe). Tolerability will be assessed by having subjects answer the treatment tolerability questions at each visit during the treatment period. The tolerability question will be assessed using a 0-3 scale for itching, burning, and stinging.

Conditions

• Verruca Vulgaris

Interventions

Type	Name	Description
DRUG	2014-ALC-919-US	A topical solution to be applied twice daily for the treatment of Common Warts
DRUG	Vehicle-Control Topical Solution	A topical solution to be applied twice daily for the treatment of Common Warts

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-06-29
• Last updated: 2016-03-09

Locations

1 site across 1 country: United States