ALC-919 For The Treatment Of Common Warts

March 8, 2016 updated by: Veloce BioPharma LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Fort Washington, Pennsylvania, United States, 19034
        • Philadelphia Institute of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALC-919 Topical Solution
ALC-919 Topical Solution will be applied twice daily to study area for the treatment of Common Warts
Drug: 2014-ALC-919-US
A topical solution to be applied twice daily for the treatment of Common Warts
Other Names:
  • ALC-919
Placebo Comparator: Vehicle-Control Topical Solution
Vehicle-Control Topical Solution will be applied twice daily to study area 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
Other Names:
  • ALC-Vehicle-Control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resolution of Common Warts (Verruca vulgaris) in Participants with Twice Daily-Applied ALC-919 vs. Vehicle in Subjects 8 years of Age and Older.
Time Frame: 12 weeks
The Global Aesthetic Improvement Scale will be used to assess number and appearance of Common Warts at each visit.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 12 weeks
The Global Aesthetic Improvement Scale will be used to assess number and appearance of Common Warts at each visit.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Veloce BioPharma LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Pollack, MD, Philadelphia Institute of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-ALC-919-US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Verruca Vulgaris

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings