HealthyNCT04050826

An Exploratory Study in Healthy Volunteers to Identify Factors Influencing Bioequivalence Studies on Moderately Lipophilic Drugs Using Dermal Open Flow Microperfusion (dOFM)

A study testing Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA), Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA) and Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany) in people with Healthy and Dermal Pharmacokinetic Measurements, run by Joanneum Research Forschungsgesellschaft mbH at 1 site in Austria.

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

The overall aim of this clinical study is to develop a general bioequivalence (BE) testing method using dermal open flow microperfusion (dOFM) for dermatological drug products. In this study BE of different lidocaine/prilocaine products will be assessed and factors that influence dOFM data variability will be… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Dermal Pharmacokinetic Measurements
What is being tested?: Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA), Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA) and Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany)
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteAustria
Study dates: 1 Sep 2019to 25 Jul 2020
Phase: Interventional
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 to 65 years inclusive.
Males and/or non-pregnant, non-breast feeding females (subjects need to be informed about adequate contraceptive methods).
Able to read, understand, and sign the written informed consent form.
Willing to follow the protocol requirements and comply with protocol restrictions.

Who cannot join

Social Habits
Smoker who is not willing to restrain from smoking during the in-house visit (Visit 2).
History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.
Medications: Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, warfarin or anticholinergic drugs, or use of any medications referred in the prescription information of the products. Hormonal contraceptive or hormone replacement therapy, routine vitamins or other prescribed medication are allowed if dose is stable.
Diseases
Congenital or idiopathic methemoglobinemia

Show all 31Show fewer

History of deep vein thrombosis (DVT)/pulmonary emboly (PE)
Inherited blood disorders (such as factor V Leiden) who are prone to hypercoagulable state
Glucose-6-phosphate dehydrogenase deficiencies
Presence of any acute or chronic diseases or malignancies unless deemed not clinically significant by the investigator.
Any reason which, in the opinion of the investigator, would prevent the subject from safely participating in the study.
Any abnormalities found at physical examination or vital signs, unless deemed not clinically significant by the investigator.
Clinically significant abnormal laboratory evaluation results, as deemed by the investigator.
Clinically significant abnormal 12-lead ECG at screening, as deemed by the investigator.
Positive results to the test for hepatitis B antigen or hepatitis C antibodies.
Positive HIV test.
Positive alcohol breath test.
Blood donation within 30 days or significant loss of blood or plasma (more than 550 ml) within 90 days prior to screening.
Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
Any food allergy, intolerance, restriction or special diet that, in the opinion of the investigator, could contraindicate the subject's participation in this study.
Known or suspected allergy/hypersensitivity to lidocaine or prilocaine, known history of sensitivity to local anesthetics of the amide type or to any other component of the product, other related products, or any inactive ingredients.
Tattoos or broken and/or damaged skin at the application areas.
Active skin diseases like psoriasis or atopic dermatitis, as judged by the investigator.
Scarring at the anterior part of the thighs.
Subjects prone to keloid or hypertrophic scar formation or any known wound healing disorder.
Recent and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.), as judged by the investigator.
Not willing to avoid excessive sun exposure, steam baths, sauna, swimming and other strenuous activities between Visit 2 and the end-of-study examination to ensure good tissue regeneration.
Not willing to refrain from shaving the anterior of the thighs or using skin care products on the anterior of the thighs for at least 5 days prior to start of Visit 2.
Pronounced hairiness on the thighs that may negatively affect BE testing.
Known allergy/hypersensitivity to any of the materials/supplies used during the study.
Presence of needle phobia.

Trial locations and contacts

1 site in 1 country.

Austria1 site

CTU - Clinical Trials Unit, Medical University Graz
Graz, 8010

Other trials in Austria

About this study

Read the detailed description

The study will involve 20 healthy adult participants. Dermal pharmacokinetic (PK) profile of three different lidocaine/prilocaine products will be assessed in parallel at different skin sites on the same participant.

For BE evaluations a reference product will be compared against itself and an approved generic test product as positive control and against a non-equivalent test product as negative control. Additionally different non-invasive measurements (e.g. TEWL) will be conducted and results will be correlated with lidocaine/prilocaine PK data to identify factors that might influence skin penetration.

dOFM probes will be inserted into the dermis to monitor the dermal drug concentrations up to 12 h post-dose in topically treated skin sites. Blood samples will be drawn to rule out systemic appearance of lidocaine and/or prilocaine.

Conditions: Healthy, Dermal Pharmacokinetic Measurements
Being tested: Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA), Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA), Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany), Dermal open flow microperfusion, Blood sampling
Keywords: Dermal open flow microperfusion

What participants receive

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

Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA)Drug
Also called Reference product
Topical application
Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA)Drug
Also called Generic test product
Topical application
Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany)Drug
Also called Non-equivalent test product
Topical application
Dermal open flow microperfusionDevice
Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentration in the dermis.
16 dOFM probes will be implanted per participant (8 test-sites; 2 dOFM probes per test-site).
From each dOFM probe 13 samples will be taken (1 pre-dose, 12 post-dose).
Blood samplingProcedure or surgery
1 sample will be taken pre-dose and 12 samples post-dose.

Study groups in NCT04050826
Study group	Role	What they receive
Dermal Pharmacokinetic study	Experimental	Measurement of dermal pharmacokinetic (PK) parameter (AUC, Cmax) of lidocaine/ prilocaine using dOFM after topical application of three lidocaine/prilocaine products in 20 participants. After baseline sampling (1 hour pre-dose) the three lidocaine/prilocaine products will be applied and removed after 3 hours. ISF and blood sampling will be continued for a duration of 12 hours post-dose. Additionally different physical parameters (e.g. TEWL) will be measured. Receives: Drug: Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA); Drug: Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA); Drug: Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany); Device: Dermal open flow microperfusion; Procedure: Blood sampling

What is being measured

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

Area under the dermal concentration versus time curve for lidocaine
Dermal concentrations (ng/mL) of lidocaine will be measured to calculate the area under the dermal concentration versus time curve AUC (ng*h/mL).
Measured: 13 hours
Area under the dermal concentration versus time curve for prilocaine
Dermal concentrations (ng/mL) of prilocaine will be measured to calculate the area under the dermal concentration versus time curve AUC (ng*h/mL).
Measured: 13 hours
Maximal dermal concentration of lidocaine
Dermal concentrations (ng/mL) of lidocaine will be measured to calculate the maximal dermal concentration (ng/mL).
Measured: 13 hours
Maximal dermal concentration of prilocaine
Dermal concentrations (ng/mL) of prilocaine will be measured to calculate the maximal dermal concentration (ng/mL).
Measured: 13 hours

Secondary outcomes (2)

Blood lidocaine concentrations versus time curve
Lidocaine concentrations (ng/mL) in the blood will be measured to obtain the concentration-time curves in the blood.
Measured: 13 hours
Blood prilocaine concentrations versus time curve
Prilocaine concentrations (ng/mL) in the blood will be measured to obtain the concentration-time curves in the blood.
Measured: 13 hours

Timeline

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

1 Sep 201925 Jul 2020

First posted8 Aug 2019
Study start1 Sep 2019
Primary completion15 Dec 2019
Study completion25 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04050826
Sponsor's protocol ID: FDA02_AIM2_Main
Status last verified: Oct 2020
First submitted: 7 Aug 2019
Last updated: 12 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Bodenlenz M, Tiffner KI, Raml R, Augustin T, Dragatin C, Birngruber T, Schimek D, Schwagerle G, Pieber TR, Raney SG, Kanfer I, Sinner F. Open Flow Microperfusion as a Dermal Pharmacokinetic Approach to Evaluate Topical Bioequivalence. Clin Pharmacokinet. 2017 Jan;56(1):91-98. doi: 10.1007/s40262-016-0442-z.
PubMed 27539717
Bodenlenz M, Dragatin C, Liebenberger L, Tschapeller B, Boulgaropoulos B, Augustin T, Raml R, Gatschelhofer C, Wagner N, Benkali K, Rony F, Pieber T, Sinner F. Kinetics of Clobetasol-17-Propionate in Psoriatic Lesional and Non-Lesional Skin Assessed by Dermal Open Flow Microperfusion with Time and Space Resolution. Pharm Res. 2016 Sep;33(9):2229-38. doi: 10.1007/s11095-016-1960-y. Epub 2016 Jun 6.
PubMed 27271272
Bodenlenz M, Aigner B, Dragatin C, Liebenberger L, Zahiragic S, Hofferer C, Birngruber T, Priedl J, Feichtner F, Schaupp L, Korsatko S, Ratzer M, Magnes C, Pieber TR, Sinner F. Clinical applicability of dOFM devices for dermal sampling. Skin Res Technol. 2013 Nov;19(4):474-83. doi: 10.1111/srt.12071. Epub 2013 Apr 13.
PubMed 23581539
Dragatin C, Polus F, Bodenlenz M, Calonder C, Aigner B, Tiffner KI, Mader JK, Ratzer M, Woessner R, Pieber TR, Cheng Y, Loesche C, Sinner F, Bruin G. Secukinumab distributes into dermal interstitial fluid of psoriasis patients as demonstrated by open flow microperfusion. Exp Dermatol. 2016 Feb;25(2):157-9. doi: 10.1111/exd.12863. Epub 2015 Nov 23. No abstract available.
PubMed 26439798
Tiffner K, Boulgaropoulos B, Hofferer C, Birngruber T, Porksen N, Linnebjerg H, Garhyan P, Lam ECQ, Knadler MP, Pieber TR, Sinner F. Quantification of Basal Insulin Peglispro and Human Insulin in Adipose Tissue Interstitial Fluid by Open-Flow Microperfusion. Diabetes Technol Ther. 2017 May;19(5):305-314. doi: 10.1089/dia.2016.0384. Epub 2017 Mar 22.
PubMed 28328234

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 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study in Healthy Volunteers to Identify Factors Influencing Bioequivalence Studies on Moderately Lipophilic Drugs Using Dermal Open Flow Microperfusion (dOFM)
ClinicalTrials.gov ID: NCT04050826
Acronym / sponsor ID: FDA02_AIM2_Main
Conditions: Healthy, Dermal Pharmacokinetic Measurements
Keywords: Dermal open flow microperfusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Joanneum Research Forschungsgesellschaft mbHUniversity, hospital or other
Study start: 1 Sep 2019 (actual)
Primary completion: 15 Dec 2019 (actual)
Study completion: 25 Jul 2020 (actual)
First posted: 8 Aug 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dermal Pharmacokinetic study	Experimental	Drug: Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA), Drug: Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA), Drug: Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany), Device: Dermal open flow microperfusion, Procedure: Blood samplingMeasurement of dermal pharmacokinetic (PK) parameter (AUC, Cmax) of lidocaine/ prilocaine using dOFM after topical application of three lidocaine/prilocaine products in 20 participants. After baseline sampling (1 hour pre-dose) the three lidocaine/prilocaine products will be applied and removed after 3 hours. ISF and blood sampling will be continued for a duration of 12 hours post-dose. Additionally different physical parameters (e.g. TEWL) will be measured.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18 to 65 years inclusive.
Males and/or non-pregnant, non-breast feeding females (subjects need to be informed about adequate contraceptive methods).
Able to read, understand, and sign the written informed consent form.
Willing to follow the protocol requirements and comply with protocol restrictions.

Key exclusion criteria (31 listed)

Social Habits
Medications: Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, warfarin or anticholinergic drugs, or use of any medications referred in the prescription information of the products. Hormonal contraceptive or hormone replacement therapy, routine vitamins or other prescribed medication are allowed if dose is stable.
Diseases
Any reason which, in the opinion of the investigator, would prevent the subject from safely participating in the study.
Any abnormalities found at physical examination or vital signs, unless deemed not clinically significant by the investigator.

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 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA)Also: Reference productTopical application	Drug	Dermal Pharmacokinetic study
Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA)Also: Generic test productTopical application	Drug	Dermal Pharmacokinetic study
Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany)Also: Non-equivalent test productTopical application	Drug	Dermal Pharmacokinetic study
Dermal open flow microperfusionDermal open flow microperfusion will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentration in the dermis. 16 dOFM probes will be implanted per participant (8 test-sites; 2 dOFM probes per test-site). From each dOFM probe 13 samples will be taken (1 pre-dose, 12 post-dose).	Device	Dermal Pharmacokinetic study
Blood sampling1 sample will be taken pre-dose and 12 samples post-dose.	Procedure or surgery	Dermal Pharmacokinetic study

Primary outcome

Area under the dermal concentration versus time curve for lidocaine
Time frame: 13 hours
Dermal concentrations (ng/mL) of lidocaine will be measured to calculate the area under the dermal concentration versus time curve AUC (ng*h/mL).
Area under the dermal concentration versus time curve for prilocaine
Time frame: 13 hours
Dermal concentrations (ng/mL) of prilocaine will be measured to calculate the area under the dermal concentration versus time curve AUC (ng*h/mL).
Maximal dermal concentration of lidocaine
Time frame: 13 hours
Dermal concentrations (ng/mL) of lidocaine will be measured to calculate the maximal dermal concentration (ng/mL).
Maximal dermal concentration of prilocaine
Time frame: 13 hours
Dermal concentrations (ng/mL) of prilocaine will be measured to calculate the maximal dermal concentration (ng/mL).

2 secondary outcomes

Blood lidocaine concentrations versus time curve
Time frame: 13 hours
Blood prilocaine concentrations versus time curve
Time frame: 13 hours

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 12 Oct 2020.
Background: PubMed 27539717Bodenlenz M, Tiffner KI, Raml R, Augustin T, Dragatin C, Birngruber T, Schimek D, Schwagerle G, Pieber TR, Raney SG, Kanfer I, Sinner F. Open Flow Microperfusion as a Dermal Pharmacokinetic Approach to Evaluate Topical Bioequivalence. Clin Pharmacokinet. 2017 Jan;56(1):91-98. doi: 10.1007/s40262-016-0442-z.
Background: PubMed 27271272Bodenlenz M, Dragatin C, Liebenberger L, Tschapeller B, Boulgaropoulos B, Augustin T, Raml R, Gatschelhofer C, Wagner N, Benkali K, Rony F, Pieber T, Sinner F. Kinetics of Clobetasol-17-Propionate in Psoriatic Lesional and Non-Lesional Skin Assessed by Dermal Open Flow Microperfusion with Time and Space Resolution. Pharm Res. 2016 Sep;33(9):2229-38. doi: 10.1007/s11095-016-1960-y. Epub 2016 Jun 6.
Background: PubMed 23581539Bodenlenz M, Aigner B, Dragatin C, Liebenberger L, Zahiragic S, Hofferer C, Birngruber T, Priedl J, Feichtner F, Schaupp L, Korsatko S, Ratzer M, Magnes C, Pieber TR, Sinner F. Clinical applicability of dOFM devices for dermal sampling. Skin Res Technol. 2013 Nov;19(4):474-83. doi: 10.1111/srt.12071. Epub 2013 Apr 13.
Background: PubMed 26439798Dragatin C, Polus F, Bodenlenz M, Calonder C, Aigner B, Tiffner KI, Mader JK, Ratzer M, Woessner R, Pieber TR, Cheng Y, Loesche C, Sinner F, Bruin G. Secukinumab distributes into dermal interstitial fluid of psoriasis patients as demonstrated by open flow microperfusion. Exp Dermatol. 2016 Feb;25(2):157-9. doi: 10.1111/exd.12863. Epub 2015 Nov 23. No abstract available.
Background: PubMed 28328234Tiffner K, Boulgaropoulos B, Hofferer C, Birngruber T, Porksen N, Linnebjerg H, Garhyan P, Lam ECQ, Knadler MP, Pieber TR, Sinner F. Quantification of Basal Insulin Peglispro and Human Insulin in Adipose Tissue Interstitial Fluid by Open-Flow Microperfusion. Diabetes Technol Ther. 2017 May;19(5):305-314. doi: 10.1089/dia.2016.0384. Epub 2017 Mar 22.
In Vivo Dermal Open Flow Microperfusion: A Novel Approach to Evaluating Topical Bioavailability and BioequivalenceLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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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.

Thomas Pieber, Prof. principal investigator

Medical University of Graz

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

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 31 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 12 Oct 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 Austria. 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.

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?

Area under the dermal concentration versus time curve for lidocaine (time frame: 13 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 NCT04050826, which also lists 5 linked publications.

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 12 Oct 2020.