Completed

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

What is being tested

2014-ALC-919-US

+ Vehicle-Control Topical Solution

Drug

Who is being recruted

DNA Virus Infections+7

+ Infections

+ Skin Diseases

From 8 to 90 Years

+25 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: April 2015

See protocol details

Summary

Principal SponsorVeloce BioPharma LLC

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2015

Actual date on which the first participant was enrolled.

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.

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

NCT02483455

Principal SponsorVeloce BioPharma LLC

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 8 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DNA Virus InfectionsInfectionsSkin DiseasesSkin Diseases, InfectiousTumor Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralSkin and Connective Tissue DiseasesPapillomavirus Infections

Criteria

13 inclusion criteria required to participate

Males or females aged 8 years or older;

Individuals with at least 1, but not exceeding 10 Common Wart(s) (Verruca vulgaris) to be treated;

Individuals whose treatment area is located anywhere on the body except for the following prohibited areas which include: the eye area (including eyelids), lips, mouth cavity, nasal cavity, inner ear, palms of the hands (including periungual area), soles of the feet (including periungual area), or the anogenital area;

Individuals who are generally in good health as determined by the Principal Investigator;

Show More Criteria

12 exclusion criteria prevent from participating

Have warts outside of the treatment area, the eye area (including eyelids), lips, mouth cavity, nasal cavity, inner ear, palms of the hands (including periungual area), soles of the feet (including periungual area), or the anogenital area) or any area that would interfere with study procedures or analyses;

Have participated in an investigational trial within 30 days prior to enrollment;

Have received cryotherapy in the treatment area within 30 days prior to enrollment;

Have required or will require systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrollment or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

ALC-919 Topical Solution will be applied twice daily to study area for the treatment of Common Warts

Group II

Placebo

Vehicle-Control Topical Solution will be applied twice daily to study area for the treatment of Common Warts

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Philadelphia Institute of Dermatology

Fort Washington, United StatesOpen Philadelphia Institute of Dermatology in Google Maps

CompletedOne Study Center