Chemotherapy-Associated ParonychiaPhase 2NCT03207906
A Trial to Evaluate the Efficacy and Safety of Two Concentrations of VBP-926 Solution for the Treatment of Chemotherapy-associated Paronychia in Cancer Patients
A Phase 2 study testing VBP-926 in people with Chemotherapy-Associated Paronychia, run by Veloce BioPharma LLC at 8 sites in United States.
Trial summary
Paronychia is inflammation of the skin surrounding the nail that leads to secondary infection. Iatrogenic paronychia has been clearly associated with cancer chemotherapies. This phase-2 trial is a dose finding study and will evaluate topical VBP-926 solution against a vehicle control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Associated Paronychia
- What is being tested?
- VBP-926
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 8 sitesUnited States
- Study dates
- 24 Oct 2017to 18 Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 years or older
- Acute paronychia developing during the course of their monotherapy or combination chemotherapy
- Involvement of at least one nail with a Paronychia Severity Grading score of 1 or higher
- Eastern Cooperative Oncology Group score ≤ 2
- Life expectancy of at least 12 months as per the investigator's judgment
- Willing to provide written informed consent
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- Individuals who are willing to not start any new products OTC or prescription treatments for Paronychia and discontinue any treatment the investigator feels may interfere with the evaluation of the test products
- Individuals who are already on antibiotics as prescribed by oncologist for any condition except paronychia
- Individuals who are willing to avoid using cosmetic products, creams, salves, or ointments to the treatment area(s)
Who cannot join
- Mentally incompetent or unable or not willing to give written informed consent or meet study requirements
- Without a history of a cancer diagnosis
- Without history of cancer diagnosis using chemotherapy
- Patients with paronychia requiring surgical intervention at baseline
- Patients who are already on prescribed treatment for paronychia who are not willing to discontinue this treatment and only use study drug (no washout period required)
- Neutropenia (absolute neutrophil count < 1500 cells/µL)
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- Patient Human Immunodeficiency Virus (HIV) infection
- Patients with any medical condition, including alcohol or drug abuse or mental incapacity / hypersensitive to the study drug, which in judgment of the investigator will interfere with the patient's participation in the study or evaluation of study results
- Have any medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Bryn Mawr Skin & Cancer Institute
Bryn Mawr, Pennsylvania, 19010
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28207
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43221
Compassionate Cancer Care
Fountain Valley, California, 92708
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
Washington University
St Louis, Missouri, 63130
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10461
About this study
Official title: A Multi-center, Randomized, Double-blind, Vehicle-controlled, Phase-2 Trial to Evaluate the Efficacy and Safety of Two Concentrations of VBP-926 Solution for the Treatment of Chemotherapy-associated Paronychia in Cancer Patients
Paronychia is inflammation of the skin surrounding the nail that leads to secondary infection. Iatrogenic paronychia has been clearly associated with cancer chemotherapies. This phase-2 trial is a dose finding study and will evaluate topical VBP-926 solution against a vehicle control.
- Conditions
- Chemotherapy-Associated Paronychia
- Being tested
- VBP-926
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBP-926Drug
Topical VBP-926 solution
| Study group | Role | What they receive |
|---|---|---|
| Lower concentration VBP-926 | Active comparator | VBP-926 solution applied to affected area BID Receives: Drug: VBP-926 |
| Higher concentration VBP-926 | Active comparator | VBP-926 solution applied to affected area BID Receives: Drug: VBP-926 |
| Vehicle | Placebo comparator | Vehicle solution applied to affected area BID Receives: Drug: VBP-926 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Downgrading of the 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) in adult cancer patients with chemotherapy-associated paronychia
Treatment responses will be assessed by clinical grading utilizing a morphologic 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) and will be assessed from baseline to 8 weeks for each affected nail.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start24 Oct 2017
- Primary completion17 Jul 2018
- Study completion18 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-Associated ParonychiaStudies 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
- Model description
- Once subjects have been determined to be eligible for participation in the study, they will be randomized to one of the three treatment arms. The randomization number will be generated according to the randomization schedule prepared prior to the start of the study. Participants will be assigned to receive assign treatment solution VBP-926 (either lower or higher concentration) or vehicle in 1:1:1 ratio using the IWRS system.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veloce BioPharma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jayashri Krishnan, PhD, Study director, JSS Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207906
- Sponsor's protocol ID
- 2017-VBP-926
- Status last verified
- Jan 2019
- First submitted
- 28 Jun 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capriotti KD, Anadkat M, Choi J, Kaffenberger B, McLellan B, Barone S, Kukoyi O, Goldfarb S, Lacouture M. A randomized phase 2 trial of the efficacy and safety of a novel topical povidone-iodine formulation for Cancer therapy-associated Paronychia. Invest New Drugs. 2019 Dec;37(6):1247-1256. doi: 10.1007/s10637-019-00825-0. Epub 2019 Jun 26.
PubMed 31240513
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Vehicle-controlled, Phase-2 Trial to Evaluate the Efficacy and Safety of Two Concentrations of VBP-926 Solution for the Treatment of Chemotherapy-associated Paronychia in Cancer Patients
- ClinicalTrials.gov ID
- NCT03207906
- Acronym / sponsor ID
- 2017-VBP-926
- Conditions
- Chemotherapy-Associated Paronychia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Veloce BioPharma LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 18 Sep 2018 (actual)
- First posted
- 5 Jul 2017 (actual)
- 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.
Paronychia is inflammation of the skin surrounding the nail that leads to secondary infection. Iatrogenic paronychia has been clearly associated with cancer chemotherapies. This phase-2 trial is a dose finding study and will evaluate topical VBP-926 solution against a vehicle control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Once subjects have been determined to be eligible for participation in the study, they will be randomized to one of the three treatment arms. The randomization number will be generated according to the randomization schedule prepared prior to the start of the study. Participants will be assigned to receive assign treatment solution VBP-926 (either lower or higher concentration) or vehicle in 1:1:1 ratio using the IWRS system.
| Arm | Type | Receives |
|---|---|---|
| Lower concentration VBP-926 | Active comparator | Drug: VBP-926VBP-926 solution applied to affected area BID |
| Higher concentration VBP-926 | Active comparator | Drug: VBP-926VBP-926 solution applied to affected area BID |
| Vehicle | Placebo comparator | Drug: VBP-926Vehicle solution applied to affected area BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females aged 18 years or older
- Acute paronychia developing during the course of their monotherapy or combination chemotherapy
- Involvement of at least one nail with a Paronychia Severity Grading score of 1 or higher
- Eastern Cooperative Oncology Group score ≤ 2
- Life expectancy of at least 12 months as per the investigator's judgment
Key exclusion criteria (9 listed)
- Mentally incompetent or unable or not willing to give written informed consent or meet study requirements
- Without a history of a cancer diagnosis
- Without history of cancer diagnosis using chemotherapy
- Patients with paronychia requiring surgical intervention at baseline
- Patients who are already on prescribed treatment for paronychia who are not willing to discontinue this treatment and only use study drug (no washout period required)
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 |
|---|---|---|
| VBP-926Topical VBP-926 solution | Drug | Higher concentration VBP-926, Lower concentration VBP-926, Vehicle |
Primary outcome
Downgrading of the 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) in adult cancer patients with chemotherapy-associated paronychia
Time frame: 8 weeks
Treatment responses will be assessed by clinical grading utilizing a morphologic 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) and will be assessed from baseline to 8 weeks for each affected nail.
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 25 Jan 2019.
- Derived from this study: PubMed 31240513Capriotti KD, Anadkat M, Choi J, Kaffenberger B, McLellan B, Barone S, Kukoyi O, Goldfarb S, Lacouture M. A randomized phase 2 trial of the efficacy and safety of a novel topical povidone-iodine formulation for Cancer therapy-associated Paronychia. Invest New Drugs. 2019 Dec;37(6):1247-1256. doi: 10.1007/s10637-019-00825-0. Epub 2019 Jun 26.
- Individual participant dataSharing planned: No
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.
Jayashri Krishnan, PhD study director
JSS Research
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VBP-926 in people with Chemotherapy-Associated Paronychia, run by Veloce BioPharma LLC at 8 sites 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 9 inclusion and 9 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 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Downgrading of the 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) in adult cancer patients with chemotherapy-associated paronychia (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03207906, which also lists 1 linked publication.
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 25 Jan 2019.