Verruca VulgarisPhase 2NCT02483455
ALC-919 For The Treatment Of Common Warts
A Phase 2 study testing 2014-ALC-919-US in people with Verruca Vulgaris, run by Veloce BioPharma LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Verruca Vulgaris
- What is being tested?
- 2014-ALC-919-US
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034
About this study
Official title: 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.
Read the 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
- Being tested
- 2014-ALC-919-US, Vehicle-Control Topical Solution
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2014-ALC-919-USDrug
Also called ALC-919
A topical solution to be applied twice daily for the treatment of Common Warts
Vehicle-Control Topical SolutionDrug
Also called ALC-Vehicle-Control
A topical solution to be applied twice daily for the treatment of Common Warts
| Study group | Role | What they receive |
|---|---|---|
| ALC-919 Topical Solution | Experimental | ALC-919 Topical Solution will be applied twice daily to study area for the treatment of Common Warts Receives: 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 Receives: Drug: Vehicle-Control Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
The Global Aesthetic Improvement Scale will be used to assess number and appearance of Common Warts at each visit.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verruca VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veloce BioPharma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Pollack, MD, Principal investigator, Philadelphia Institute of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483455
- Sponsor's protocol ID
- 2014-ALC-919-US
- Status last verified
- Mar 2016
- First submitted
- 21 Apr 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALC-919 For The Treatment Of Common Warts (Verruca Vulgaris)
- ClinicalTrials.gov ID
- NCT02483455
- Acronym / sponsor ID
- 2014-ALC-919-US
- Conditions
- Verruca Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Veloce BioPharma LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALC-919 Topical Solution | Experimental | Drug: 2014-ALC-919-USALC-919 Topical Solution will be applied twice daily to study area for the treatment of Common Warts |
| Vehicle-Control Topical Solution | Placebo comparator | Drug: Vehicle-Control Topical SolutionVehicle-Control Topical Solution will be applied twice daily to study area for the treatment of Common Warts |
Who may qualify
- Ages
- 8 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2014-ALC-919-USAlso: ALC-919A topical solution to be applied twice daily for the treatment of Common Warts | Drug | ALC-919 Topical Solution |
| Vehicle-Control Topical SolutionAlso: ALC-Vehicle-ControlA topical solution to be applied twice daily for the treatment of Common Warts | Drug | Vehicle-Control Topical Solution |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Pollack, MD principal investigator
Philadelphia Institute of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2014-ALC-919-US in people with Verruca Vulgaris, run by Veloce BioPharma LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.