Heat EffectEarly Phase 1NCT03145207

PK and DPK of Lidocaine Dermal Products

A Early Phase 1 study testing Lidocaine patch in people with Heat Effect, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a bioequivalence study to compare lidocaine release between a brand name and generic skin patches in healthy adults. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Heat Effect
What is being tested?: Lidocaine patch
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 14 Dec 2016to 15 May 2020
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Men or non-pregnant, women who are of any ethnic background between the age of 18 and 45 years old.
Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products.
Provide written informed consent before initiation of any of the study procedures.
Agrees not to participate in another clinical trial/study or to participate in an investigational drug study for at least 1 month after the last study session.
Able to adhere to the study restrictions and protocol schedule.
Able to participate in all study sessions.

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Has a volar forearm of either at least 24 cm (9.45 inches) in length or of sufficient size that can accommodate the formulations to be tested in a study area that begins at least 5 cm (1.97 inches) above the wrist and ends a minimum of 0.5 cm (0.197 inches) below the antecubital fossa (i.e., the bend in the arm at the elbow).
Subjects have upper arms (minimum 28 cm (11 inch) circumference) large enough to allow for the placement of two 140 cm2 patches on one upper arm or one 140 cm2 patch on each upper arm.
Subjects deemed to be healthy as judged by the MAI and determined by medical history, physical examination and medication history.
Negative urine drug screening test.
Have normal screening laboratories for WBC, CBC, Hgb, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT and AST.
Have normal screening laboratories for urine protein and urine glucose.
Female subjects must be of non-childbearing potential (as defined as surgically sterile [i.e., history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of each procedure day, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner.
Agrees not to donate blood to a blood bank throughout participation in the study and at least 3 months after the last procedure day.
Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block. (sinus rhythm is between 55-100 beats per minute).
Have normal vital signs:
Temperature 35-37.9°C (95-100.3°F)
Systolic blood pressure 90-140 mmHg
Diastolic blood pressure 60-90 mmHg
Heart rate 55-100 beats per minute
Respiration rate 12-20 breaths per minute

Who cannot join

Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of each study session.
Smokers (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes).
Participation in any ongoing investigational drug trial/study or clinical drug trial/study.
History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression.
Active positive Hepatitis B, C and/or HIV serologies (see Appendix B).
Known anemia.

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Positive urine drug screening test.
Use of chronic prescription medication during the period 0 to 30 days; or over-the counter medication (e.g. antihistamines or topical corticosteroids) and short term (<30 days) prescription medications during the period 0 to 3 days before a study session (vitamin, herbal supplements and birth control medications not included).
Donation or loss of greater than one pint of blood within 60 days of entry to the study.
Any prior adverse reaction to lidocaine. Hypersensitivity to lidocaine, known history of hypersensitivity to local anesthetics of the amide type, other excipients in the patches tested or to adhesives on tapes used to cover or tape strip treatment sites.
Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month before enrollment in this study or expects to receive an experimental agent during the study.
Any condition that would, in the opinion of the Medically Accountable Investigator (MAI), place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Consumption of alcohol within 24 h prior to dose administration.
History as either reported by the subject or evident to the investigator of infectious disease or skin infection or of chronic skin disease (e.g., diabetes, psoriasis, atopic dermatitis).
Hereditary skin disorders or any skin inflammatory conditions as reported by the research participant or evident to the MAI.
History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and did not involve the investigative sites.
Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at application site (volar forearms/upper arms), sunburn, raised moles and scars, open sores at application site (volar forearms/upper arms), scar tissue, tattoo or coloration that would interfere with placement of formulations, skin assessment or reactions to lidocaine.
BMI ≥30 kg/m2.

Trial locations and contacts

1 site in 1 country.

United States1 site

General Clinical Research Center (GCRC) at the University of
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Evaluation of Bioavailability of Lidocaine Dermal Products

This is a bioequivalence study to compare lidocaine release between a brand name and generic skin patches in healthy adults.

Read the detailed description

This research study is intended to determine the effect of heat on lidocaine patches. This study will use lidocaine patches (brand name and generic patches) that have been approved by the Food and Drug Administration (FDA) and are already sold to customers in the United States, and will not include any placebos.

Conditions: Heat Effect
Being tested: Lidocaine patch

What participants receive

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

Lidocaine patchDrug
Also called skin patch
lidocaine patch

Study groups in NCT03145207
Study group	Role	What they receive
name brand patch	Other	name brand lidocaine patch Receives: Drug: Lidocaine patch
generic patch	Other	generic lidocaine patch Receives: Drug: Lidocaine patch
name brand patch-early	Other	name brand lidocaine patch-early Receives: Drug: Lidocaine patch
name brand patch-late	Other	name brand lidocaine patch-late Receives: Drug: Lidocaine patch
generic patch-early	Other	generic lidocaine patch-early Receives: Drug: Lidocaine patch
generic patch-late	Other	generic lidocaine patch-late Receives: Drug: Lidocaine patch
both patches	Other	brand name and generic lidocaine patch Receives: Drug: Lidocaine patch

What is being measured

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

Measurement of Maximum Serum Concentration (Cmax)
maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered
Measured: six study sessions for each participant; through 15 h each study session

Timeline

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

14 Dec 201615 May 2020

First posted9 May 2017
Study start14 Dec 2016
Primary completion10 Jan 2019
Study completion15 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heat EffectStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
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: Early Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03145207
Sponsor's protocol ID: HP-00067033
Status last verified: Jun 2020
First submitted: 3 May 2017
Last updated: 9 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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?

See locations

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
Evaluation of Exercise With Overdressing to Induce Heat Acclimation in an Average Fitness Warfighter
Heat Acclimation and Thermotolerance
Not yet recruiting
Rapid Cool: Heat Stroke Treatment
Hyperthermia
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruiting
Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer
Prostate Cancer

All Heat Effect trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Bioavailability of Lidocaine Dermal Products
ClinicalTrials.gov ID: NCT03145207
Acronym / sponsor ID: HP-00067033
Conditions: Heat Effect
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: Food and Drug Administration (FDA)
Study start: 14 Dec 2016 (actual)
Primary completion: 10 Jan 2019 (actual)
Study completion: 15 May 2020 (actual)
First posted: 9 May 2017 (actual)
Results: Posted 22 Jun 2020

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 bioequivalence study to compare lidocaine release between a brand name and generic skin patches in healthy adults.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
name brand patch	Other	Drug: Lidocaine patchname brand lidocaine patch
generic patch	Other	Drug: Lidocaine patchgeneric lidocaine patch
name brand patch-early	Other	Drug: Lidocaine patchname brand lidocaine patch-early
name brand patch-late	Other	Drug: Lidocaine patchname brand lidocaine patch-late
generic patch-early	Other	Drug: Lidocaine patchgeneric lidocaine patch-early
generic patch-late	Other	Drug: Lidocaine patchgeneric lidocaine patch-late
both patches	Other	Drug: Lidocaine patchbrand name and generic lidocaine patch

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (21 listed)

Men or non-pregnant, women who are of any ethnic background between the age of 18 and 45 years old.
Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products.
Provide written informed consent before initiation of any of the study procedures.
Agrees not to participate in another clinical trial/study or to participate in an investigational drug study for at least 1 month after the last study session.
Able to adhere to the study restrictions and protocol schedule.

Key exclusion criteria (18 listed)

Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of each study session.
Smokers (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes).
Participation in any ongoing investigational drug trial/study or clinical drug trial/study.
History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression.
Active positive Hepatitis B, C and/or HIV serologies (see Appendix B).

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
Lidocaine patchAlso: skin patchlidocaine patch	Drug	both patches, generic patch, generic patch-early, generic patch-late, name brand patch, name brand patch-early, name brand patch-late

Primary outcome

Measurement of Maximum Serum Concentration (Cmax)
Time frame: six study sessions for each participant; through 15 h each study session
maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered

Results and safety

Results posted to the registry on 22 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lidocaine	14	12

Primary outcome: Measurement of Maximum Serum Concentration (Cmax)

Time frame: six study sessions for each participant; through 15 h each study session. Mean (Standard Deviation). Unit: ng/mL

Measure	Lidocaine Name Brand Patch n = 12	Lidocaine Generic Patch n = 12	Lidocaine Name Brand Patch Early Heat n = 12	Lidocaine Name Brand Patch Late Heat n = 12	Lidocaine Generic Early Heat n = 12	Lidocaine Generic Late Heat n = 12
Value	306.8 (756.3)	214.9 (280.5)	390.76 (387.29)	286.49 (288.59)	368.09 (348.93)	314.95 (287.36)

Adverse events

Time frame: TL-001 (58 days), TL-003 (113 days), TL-005 (135 days), TL-007 (62 days), TL-010 (72 days), TL-017 (388 days), TL-020 (272 days), TL-022 (693 days), TL-023 (61 days), TL-025 (358 days), TL-030 (97 days), TL-031 (108 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Name Brand Patch	0 of 14 (0%)	13 of 14 (92.9%)	0 of 14
Generic Patch	0 of 14 (0%)	9 of 14 (64.3%)	0 of 14
Name Brand Patch-early	0 of 13 (0%)	11 of 13 (84.6%)	0 of 13
Name Brand Patch-late	0 of 13 (0%)	11 of 13 (84.6%)	0 of 13
Generic Patch-early	0 of 12 (0%)	12 of 12 (100%)	0 of 12
Generic Patch-late	0 of 12 (0%)	12 of 12 (100%)	0 of 12
Both Patches	0 of 12 (0%)	12 of 12 (100%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heat Effect

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
Evaluation of Exercise With Overdressing to Induce Heat Acclimation in an Average Fitness Warfighter
Heat Acclimation and Thermotolerance
Not yet recruiting
Rapid Cool: Heat Stroke Treatment
Hyperthermia
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruiting
Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer
Prostate Cancer

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.

Audra Stinchcomb, PhD principal investigator

University of Maryland Baltimore School of Pharmacy

Hazem Hassan, PhD principal investigator

University of Maryland Baltimore School of Pharmacy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Lidocaine patch in people with Heat Effect, run by University of Maryland, Baltimore 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 21 inclusion and 18 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 Jul 2020. 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Measurement of Maximum Serum Concentration (Cmax) (time frame: six study sessions for each participant; through 15 h each study session). 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 NCT03145207.

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 Jul 2020.