PainPhase 2NCT02689713

Pilot Study to Compare Topical Voriconazole to Placebo as a Pain Reducing Agent

A Phase 2 study testing Voriconazole (topical) in people with Pain and Thermal Injury, run by Kenneth Hargreaves at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study seeks to test if the study drug (voriconazole), when applied topically to a burn wound on the skin will help to reduce pain. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Pain, Thermal Injury, Burns
What is being tested?: Voriconazole (topical)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 15 Jun 2018to 14 Nov 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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

1.1 Subject must be at least 18 years of age and no older than 60 years of age of either gender and in good general health.
1.2 Subject has sustained burn wounds of less than 30 percent of the total body surface area, in order to minimize the systemic effects on wound healing and the risk of infection (both of which increase with increasing burn size).
1.3 Subject has sustained Burn or trauma/orthopedic wounds do not involve the harvesting area.
1.4 Subject has sustained burn or trauma/orthopedic wounds that, in the judgment of the attending surgeon, require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surfaces areas. Note: Only two donor sites will be studied, however if the subject requires more than two donor sites, they will not be excluded.
1.5 The scheduled excision and grafting procedure is the first such operation for the subject during this hospitalization and injury.
1.6 Subject agrees to participate in follow-up evaluations (Post Op Day 0-3 and one follow up appointment between Post Op day 30-45 for Donor site evaluation and photos of both donor sites.

Who cannot join

2.1 Critical illnesses such as those requiring ventilator support, or having a systemic infection or hemodynamic instability, defined as a mean arterial pressure less than 60 for an extended period of time or requiring vasoactive medications to support blood pressure.
2.2 Patients unable to accurately communicate pain secondary to medical illness, altered mental status, spinal cord injury, and known current narcotic drug use.
2.3 Patients unable to make his/her own decision for the informed consent. (Not seeking consent from the legal authorized representative; self consent only).
2.4 Major acute or chronic medical illnesses that could affect wound healing (e.g. peripheral vascular disease, blood clotting disorder).
2.6 Cellulitis or other infection of the potential donor sites.
2.7 Donor site has been previously harvested for grafting.

Show all 12Show fewer

2.8 Donor site crosses a joint.
2.9 Any Corticosteroid use that could interfere with wound healing thus OLAM levels.
2.10 Subjects with greater than 30% total body surface area burns.
2.11 Pregnancy or lactation. (Beta HCG pregnancy test completed prior to operative procedure, not part of study) In the event that we have a record of a hysterectomy, no pregnancy test will be done, and the subject will be assumed NOT to be pregnant.
2.12 Prisoners.
2.13 Subjects having any contraindications for voriconazole. The contraindications are 1) known hypersensitivity to voriconazole; and 2) Coadministration of terfenadine, astemizole, cisapride, pimozide, quinidine or sirolimus, rifampin, carbamazepine, long acting barbiturates, high dose ritonavir, rifabutin, ergotamine, dihydroergotamine, oral contraceptives or St. John's Wort. A one week washout shall be determined for the above listed medications prior to allowing entry into the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

San Antonio Military Medical Center
San Antonio, Texas, 78234

Other trials in United States

About this study

Official title: Prospective, Randomized, Double-blind Controlled Pilot Study to Compare Topical Voriconazole to Placebo as a Pain Reducing Agent at Skin Donor Sites

This study seeks to test if the study drug (voriconazole), when applied topically to a burn wound on the skin will help to reduce pain.

Read the detailed description

This single-center, prospective, randomized, double-blind, controlled pilot study conducted at San Antonio Military Medical Center will evaluate the effectiveness of topical voriconazole for pain relief at autogenous skin donor sites compared to a topical placebo application. The patients will act as their own control. All participants and investigators in the study will be blinded to the treatment arm utilized on each of the patient's donor sites (voriconazole versus placebo). Patients, who are scheduled for skin grafting and have met the inclusion criteria for this study, will be invited to enroll in the study. Only those patients who have been planned for skin graft sites that are approximately symmetrical in size will be allowed to enroll in the study. The donor site wounds will be studied using a paired design consisting of voriconazole or the placebo applied topically to same-patient matched donor sites. Patients will be queried via the pain assessment tool as to perceived pain at timed intervals. Dialysate samples will be collected via microdialysis probes at matching timed intervals in order to measure levels of oxidized linoleic acid metabolites shown in previous studies to be present in peripheral nerves.

Conditions: Pain, Thermal Injury, Burns, Hyperalgesia
Being tested: Voriconazole (topical), Topical Sterile Water Placebo Group
Keywords: Burn Pain, Hyperalgesia, TRPV1, OLAMs
Medical subject headings: Pain, Burns, Hyperalgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Voriconazole (topical)Drug
Also called Vfend IV 200mg
The voriconazole (Vfend®-IV 200mg) will be applied topically to one of two skin graft sites at a concentration of 150 micromolar. Dialysates will be collected over 12 hours post-skin graft/voriconazole application for analysis in the lab of OLAM concentrations.
Topical Sterile Water Placebo GroupDrug
Also called Sterile Water Placebo
Sterile water will be applied topically to the other of the two skin graft sites. Dialysates will be collected over 12 hours post-skin graft/sterile water application for analysis in the lab of OLAM concentrations.

Study groups in NCT02689713
Study group	Role	What they receive
Topical Voriconazole Study Drug Group	Experimental	Subjects between 18 and 60 years old who have sustained a burn wound of less than 30% total body surface area, or traumatic wounds requiring skin graft will have the Topical Voriconazole study drug placed on graft site. Receives: Drug: Voriconazole (topical)
Topical Sterile Water Placebo Group	Placebo comparator	Subjects between 18 and 60 years old who have sustained a burn wound of less than 30% total body surface area, or traumatic wounds requiring skin graft will have the Topical Sterile Water Placebo placed on graft site. Receives: Drug: Topical Sterile Water Placebo Group

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Levels reported by patient on the Four Point Category Pain Scale at specific timepoints over 72 hours will be compared to pre-operative baseline pain report.
Subjects will complete a pre-op pain assessment tool (Four Point Category Pain Scale consisting of 0-3 numeric with corresponding adjectives), then complete the same instrument at 1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours post-procedure.
Measured: Pre-operatively then over 72 hours post-skin graft procedure (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)
Pain Levels reported by the patient on the Heft-Parker Pain Scale at specific timepoints over 72 hours will be compared to pre-operative baseline pain report.
Subjects will complete a pre-op pain assessment tool (Heft-Parker Pain Scale - 170mm), then complete the same instrument at 1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours post-procedure.
Measured: Pre-operatively then over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)
Pain Levels reported by the patient on the Visual Analog Pain Scale at specific timepoints over 72 hours compared to pre-operative baseline pain report.
Subjects will complete a pre-op pain assessment tool (Visual Analog Pain Scale - 100mm), then complete the same instrument at 1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours post-procedure.
Measured: Pre-operatively then over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)
Cutaneous dialysate levels collected over time to measure baseline vs. timepoint oxidized linoleic acid metabolites (OLAMs) levels.
Microdialysates will be collected from the CMA-70 probe and CMA-106 pump at 1, 2, 3, 6, 9,12, 24, 36, 48,60, and 72 hours post drug administration [+/- 20 minutes per time interval]. The specific timepoint dialysates levels will be analysed and compared to baseline.
Measured: Over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)

Secondary outcomes (1)

Skin graft donor site wounds compared for cosmetic healing via photograph at post-op visit
Digital photographs of the wounds will be taken at the post-op visit scheduled between 30-45 days after the skin graft procedure to assess the cosmetic appearance of the two wound sites.
Measured: At scheduled post-op visit between 30-45 days post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201814 Nov 2018

First posted24 Feb 2016 (estimated)
Study start15 Jun 2018 (estimated)
Primary completion14 Nov 2018
Study completion14 Nov 2018

Why it stopped: Inability to recruit subjects at the study site.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PainStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02689713
Sponsor's protocol ID: HSC20120196H
Status last verified: Dec 2018
First submitted: 4 Feb 2016
Last updated: 17 Dec 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No plan to share data.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized, Double-blind Controlled Pilot Study to Compare Topical Voriconazole to Placebo as a Pain Reducing Agent at Skin Donor Sites
ClinicalTrials.gov ID: NCT02689713
Acronym / sponsor ID: HSC20120196H
Conditions: Pain, Thermal Injury, Burns, Hyperalgesia
Keywords: Burn Pain, Hyperalgesia, TRPV1, OLAMs
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Inability to recruit subjects at the study site.
Enrolment: 0 participants (actual)
Lead sponsor: Kenneth HargreavesUniversity, hospital or other
Collaborators: San Antonio Military Medical Center, U.S. Army Medical Research and Development Command
Study start: 15 Jun 2018 (estimated)
Primary completion: 14 Nov 2018 (actual)
Study completion: 14 Nov 2018 (actual)
First posted: 24 Feb 2016 (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 study seeks to test if the study drug (voriconazole), when applied topically to a burn wound on the skin will help to reduce pain.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Topical Voriconazole Study Drug Group	Experimental	Drug: Voriconazole (topical)Subjects between 18 and 60 years old who have sustained a burn wound of less than 30% total body surface area, or traumatic wounds requiring skin graft will have the Topical Voriconazole study drug placed on graft site.
Topical Sterile Water Placebo Group	Placebo comparator	Drug: Topical Sterile Water Placebo GroupSubjects between 18 and 60 years old who have sustained a burn wound of less than 30% total body surface area, or traumatic wounds requiring skin graft will have the Topical Sterile Water Placebo placed on graft site.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

1.1 Subject must be at least 18 years of age and no older than 60 years of age of either gender and in good general health.
1.2 Subject has sustained burn wounds of less than 30 percent of the total body surface area, in order to minimize the systemic effects on wound healing and the risk of infection (both of which increase with increasing burn size).
1.3 Subject has sustained Burn or trauma/orthopedic wounds do not involve the harvesting area.
1.4 Subject has sustained burn or trauma/orthopedic wounds that, in the judgment of the attending surgeon, require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surfaces areas. Note: Only two donor sites will be studied, however if the subject requires more than two donor sites, they will not be excluded.
1.5 The scheduled excision and grafting procedure is the first such operation for the subject during this hospitalization and injury.

Key exclusion criteria (12 listed)

2.1 Critical illnesses such as those requiring ventilator support, or having a systemic infection or hemodynamic instability, defined as a mean arterial pressure less than 60 for an extended period of time or requiring vasoactive medications to support blood pressure.
2.2 Patients unable to accurately communicate pain secondary to medical illness, altered mental status, spinal cord injury, and known current narcotic drug use.
2.3 Patients unable to make his/her own decision for the informed consent. (Not seeking consent from the legal authorized representative; self consent only).
2.4 Major acute or chronic medical illnesses that could affect wound healing (e.g. peripheral vascular disease, blood clotting disorder).
2.6 Cellulitis or other infection of the potential donor sites.

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
Voriconazole (topical)Also: Vfend IV 200mgThe voriconazole (Vfend®-IV 200mg) will be applied topically to one of two skin graft sites at a concentration of 150 micromolar. Dialysates will be collected over 12 hours post-skin graft/voriconazole application for analysis in the lab of OLAM concentrations.	Drug	Topical Voriconazole Study Drug Group
Topical Sterile Water Placebo GroupAlso: Sterile Water PlaceboSterile water will be applied topically to the other of the two skin graft sites. Dialysates will be collected over 12 hours post-skin graft/sterile water application for analysis in the lab of OLAM concentrations.	Drug	Topical Sterile Water Placebo Group

Primary outcome

Pain Levels reported by patient on the Four Point Category Pain Scale at specific timepoints over 72 hours will be compared to pre-operative baseline pain report.
Time frame: Pre-operatively then over 72 hours post-skin graft procedure (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)
Subjects will complete a pre-op pain assessment tool (Four Point Category Pain Scale consisting of 0-3 numeric with corresponding adjectives), then complete the same instrument at 1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours post-procedure.
Pain Levels reported by the patient on the Heft-Parker Pain Scale at specific timepoints over 72 hours will be compared to pre-operative baseline pain report.
Time frame: Pre-operatively then over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)
Subjects will complete a pre-op pain assessment tool (Heft-Parker Pain Scale - 170mm), then complete the same instrument at 1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours post-procedure.
Pain Levels reported by the patient on the Visual Analog Pain Scale at specific timepoints over 72 hours compared to pre-operative baseline pain report.
Time frame: Pre-operatively then over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)
Subjects will complete a pre-op pain assessment tool (Visual Analog Pain Scale - 100mm), then complete the same instrument at 1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours post-procedure.
Cutaneous dialysate levels collected over time to measure baseline vs. timepoint oxidized linoleic acid metabolites (OLAMs) levels.
Time frame: Over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)
Microdialysates will be collected from the CMA-70 probe and CMA-106 pump at 1, 2, 3, 6, 9,12, 24, 36, 48,60, and 72 hours post drug administration [+/- 20 minutes per time interval]. The specific timepoint dialysates levels will be analysed and compared to baseline.

1 secondary outcome

Skin graft donor site wounds compared for cosmetic healing via photograph at post-op visit
Time frame: At scheduled post-op visit between 30-45 days post-procedure

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
Individual participant dataSharing planned: No. No plan to share data.

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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.

Christopher E White, MD principal investigator

Brook Army Medical Center

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 Voriconazole (topical) in people with Pain and Thermal Injury, run by Kenneth Hargreaves 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 6 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: withdrawn, as of the sponsor's last update on 17 Dec 2018. 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 was withdrawn before enrolling participants, so there are no results.

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?

Pain Levels reported by patient on the Four Point Category Pain Scale at specific timepoints over 72 hours will be compared to pre-operative baseline pain report. (time frame: Pre-operatively then over 72 hours post-skin graft procedure (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)). The study lists 4 primary outcomes in all. 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 NCT02689713.

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 17 Dec 2018.