ALC-919 For The Treatment Of Common Warts

NCT02483455 | Completed Phase 2 DMC

• 1 other identifier: 2014-ALC-919-US
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Verruca Vulgaris

Outcome Measures

Primary Outcomes (1)

• Resolution of Common Warts (Verruca vulgaris) in Participants with Twice Daily-Applied ALC-919 vs. Vehicle in Subjects 8 years of Age and Older.

  The Global Aesthetic Improvement Scale will be used to assess number and appearance of Common Warts at each visit.

  12 weeks

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability with Twice Daily-Applied ALC-919 vs. Vehicle in Subjects 8 Years of Age and Older with Common Warts (Verruca vulgaris).

  12 weeks

Study Arms (2)

ALC-919 Topical Solution

EXPERIMENTAL

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

Drug: 2014-ALC-919-US

Vehicle-Control Topical Solution

PLACEBO COMPARATOR

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

Drug: Vehicle-Control Topical Solution

Interventions

2014-ALC-919-US DRUG

A topical solution to be applied twice daily for the treatment of Common Warts

Also known as: ALC-919

ALC-919 Topical Solution

Vehicle-Control Topical Solution DRUG

A topical solution to be applied twice daily for the treatment of Common Warts

Also known as: ALC-Vehicle-Control

Vehicle-Control Topical Solution

Eligibility Criteria

• Age: 8 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Willingness and ability to read, understand, and sign the IRB-approved informed consent form in English after the nature of the study has been fully explained and questions have been answered;
• Individuals who are willing to not start any new products OTC or prescription treatments and discontinue any treatment the Principal Investigator feels may interfere with the evaluation of the test products;
• Individuals who are willing to avoid using cosmetic products, creams, salves, or ointments to the treatment area(s);
• Individuals who are willing and able to thoroughly follow the product use instructions, attend all the scheduled visits and successfully complete the study;
• Individuals who are willing and able to not begin any office based treatments for the duration of the study;
• Individuals who are determined to be free of any systemic or dermatologic disorder, which, in the opinion of the Principal Investigator, will interfere with the study results;
• Female subjects determined to be of child-bearing potential must indicate to the best of their knowledge they are not pregnant and/or lactating nor do they intend to become pregnant during their participation in the study;
• Female subjects with reproductive potential must agree to practice medically acceptable form of birth control during the study;
• A female subject who is post-menopausal (amenorrhea for 12 months prior to the Baseline Visit) is not considered of reproductive potential.

You may not qualify if:

• 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
• Have any uncontrolled current infection;
• Female subject who is pregnant, lactating planning to become pregnant, or is breastfeeding;
• Have any chronic or acute medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk (such as an immunodeficiency or relevant genetic syndrome);
• Have any active malignancy or are undergoing treatment for any malignancy other than non-melanoma skin cancer;
• Individuals who are mentally incompetent, unable or not willing to give written informed consent or meet study requirements;
• Subjects viewed by the Principal Investigator as not being able to complete the study.
• Subjects have a known history of irritation or allergy caused by povidone-iodine
• Have an excessive number of Common Warts (Verruca vulgaris), defined as greater than 10

Sponsors & Collaborators

• Veloce BioPharma LLC: lead

Study Sites (1)

Philadelphia Institute of Dermatology

Fort Washington, Pennsylvania, 19034, United States

Location

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrew Pollack, MD

  Philadelphia Institute of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: June 29, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 9, 2016

Record last verified: 2016-03

Locations

US (1)