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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-07-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 evaluated.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Exploratory Study in Healthy Volunteers to Investigate the Cross-talk Between Local Drug Concentrations in the Skin and Systemic Concentrations During Topical Bioequivalence Studies Using Dermal Sampling Techniques

NCT03813030

Healthy Dermal Pharmacokinetic Measurement

COMPLETED NA

Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure

NCT04784728

Healthy

COMPLETED PHASE1

Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel

NCT01591616

Periodontal Disease

COMPLETED PHASE4

Pharmacokinetic Study of Nanoencapsulated Gel of Lidocaine, Prilocaine and Combination of Lidocaine and Prilocaine

NCT03441841

Topical Anesthesia

COMPLETED PHASE1

A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral Cavity

NCT03629041

Topical Anaesthesia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Dermal Pharmacokinetic Measurements

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dermal Pharmacokinetic study

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.

Group Type EXPERIMENTAL

Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA)

Intervention Type DRUG

Topical application

Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA)

Intervention Type DRUG

Topical application

Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany)

Intervention Type DRUG

Topical application

Dermal open flow microperfusion

Intervention Type DEVICE

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 sampling

Intervention Type PROCEDURE

1 sample will be taken pre-dose and 12 samples post-dose.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA)

Topical application

Intervention Type DRUG

Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA)

Topical application

Intervention Type DRUG

Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany)

Topical application

Intervention Type DRUG

Dermal open flow microperfusion

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).

Intervention Type DEVICE

Blood sampling

1 sample will be taken pre-dose and 12 samples post-dose.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Reference product Generic test product Non-equivalent test product

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 18 to 65 years inclusive.
2. Males and/or non-pregnant, non-breast feeding females (subjects need to be informed about adequate contraceptive methods).
3. Able to read, understand, and sign the written informed consent form.
4. Willing to follow the protocol requirements and comply with protocol restrictions.

Exclusion Criteria

1. Social Habits

1. Smoker who is not willing to restrain from smoking during the in-house visit (Visit 2).
2. History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.
2. 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.
3. Diseases

1. Congenital or idiopathic methemoglobinemia
2. History of deep vein thrombosis (DVT)/pulmonary emboly (PE)
3. Inherited blood disorders (such as factor V Leiden) who are prone to hypercoagulable state
4. Glucose-6-phosphate dehydrogenase deficiencies
5. Presence of any acute or chronic diseases or malignancies unless deemed not clinically significant by the investigator.
4. Any reason which, in the opinion of the investigator, would prevent the subject from safely participating in the study.
5. Any abnormalities found at physical examination or vital signs, unless deemed not clinically significant by the investigator.
6. Clinically significant abnormal laboratory evaluation results, as deemed by the investigator.
7. Clinically significant abnormal 12-lead ECG at screening, as deemed by the investigator.
8. Positive results to the test for hepatitis B antigen or hepatitis C antibodies.
9. Positive HIV test.
10. Positive alcohol breath test.
11. Blood donation within 30 days or significant loss of blood or plasma (more than 550 ml) within 90 days prior to screening.
12. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
13. Any food allergy, intolerance, restriction or special diet that, in the opinion of the investigator, could contraindicate the subject's participation in this study.
14. 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.
15. Tattoos or broken and/or damaged skin at the application areas.
16. Active skin diseases like psoriasis or atopic dermatitis, as judged by the investigator.
17. Scarring at the anterior part of the thighs.
18. Subjects prone to keloid or hypertrophic scar formation or any known wound healing disorder.
19. Recent and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.), as judged by the investigator.
20. 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.
21. 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.
22. Pronounced hairiness on the thighs that may negatively affect BE testing.
23. Known allergy/hypersensitivity to any of the materials/supplies used during the study.
24. Presence of needle phobia.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes