A Study to Assess Therapeutic Equivalence Between Test EMLA Patch With Marketed EMLA Patch in Healthy Subjects.

NCT ID: NCT03313336

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2017-11-09

Brief Summary

A double-blind, randomized, 2-period, placebo-controlled, single-center, crossover study, efficacy study demonstrating the therapeutic equivalence of the test cellulose disc (matrix) in EMLA patch and the current commercial cellulose disc (matrix) in EMLA patch in healthy subjects.

Detailed Description

This study will be a double-blind, randomized, 2-period, placebo-controlled, crossover study in healthy male and female subjects, performed at a single study center. Prior to inclusion, informed consent will be obtained. A brief medical history, including limited demographic data (gender, age and ethnicity) will be recorded, and eligibility for inclusion to the study will be established through a physical inspection of hands. Subjects will be shown how to complete the VAS. Visual analogue scale (VAS) as a research tool is frequently used for the assessment of pain severity and relief. VAS is easy to use and can be applied in a variety of settings; results are reproducible. VAS data are sensitive to treatment effects and can be analyzed using parametric statistical techniques. At each specific study visit, each subject will undergo a left-right comparison of two patch preparations, followed by a repeated test with an alternate combination of preparations. Thus, the study will comprise: Visit 1: EMLA Test Patch plus Placebo Patch OR EMLA Test Patch plus EMLA current Reference Patch. Visit 2: EMLA Test Patch plus EMLA current Reference Patch OR EMLA Test Patch plus Placebo Patch. There will be a washout period of at minimum of 4 calendar days between treatment periods (visits). No follow-up visit is needed. Any adverse event (AE) that is ongoing at the last visit will be followed up as appropriate.

Conditions

Pain

Keywords

Dermal anesthesia.; Venipuncture and intravenous cannulation.; Skin blanching or erythema.; Phase I.; Therapeutic equivalence.; Eutectic Mixture of Local anaesthetics (EMLA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

EMLA Test Patch.

Group Type: ACTIVE_COMPARATOR

EMLA test patch

Intervention Type: DRUG

EMLA® Test Patch containing the active ingredients lidocaine base 25 mg/g and prilocaine base 25 mg/g in an oil-in-water emulsion saturating the absorbent cellulose disc. The source of cellulose for the cellulose disc will be provided from a new supplier in this test patch.

Cohort 2

EMLA Reference Patch.

Group Type: ACTIVE_COMPARATOR

EMLA current reference patch

Intervention Type: DRUG

EMLA current Reference Patch, containing the active ingredients lidocaine base 25 mg/g and prilocaine base 25 mg/g in an oil-in-water emulsion saturating the absorbent cellulose disc.

Cohort 3

Placebo patch.

Group Type: PLACEBO_COMPARATOR

Placebo Patch

Intervention Type: DRUG

Placebo Patch, based on the EMLA Test Patch (incorporating the absorbent cellulose disc with cellulose from the current supplier), where the absorbent disc will be saturated with a placebo oil-in-water emulsion, where the eutectic mixture of lidocaine and prilocaine is replaced with fractionated coconut oil and chlorhexidine digluconate 20%, with identical appearance to the active EMLA patches.

Interventions

EMLA test patch

EMLA® Test Patch containing the active ingredients lidocaine base 25 mg/g and prilocaine base 25 mg/g in an oil-in-water emulsion saturating the absorbent cellulose disc. The source of cellulose for the cellulose disc will be provided from a new supplier in this test patch.

Intervention Type: DRUG

EMLA current reference patch

EMLA current Reference Patch, containing the active ingredients lidocaine base 25 mg/g and prilocaine base 25 mg/g in an oil-in-water emulsion saturating the absorbent cellulose disc.

Intervention Type: DRUG

Placebo Patch

Placebo Patch, based on the EMLA Test Patch (incorporating the absorbent cellulose disc with cellulose from the current supplier), where the absorbent disc will be saturated with a placebo oil-in-water emulsion, where the eutectic mixture of lidocaine and prilocaine is replaced with fractionated coconut oil and chlorhexidine digluconate 20%, with identical appearance to the active EMLA patches.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Provision of signed and dated, written informed consent prior to any study specific procedures.

2. Healthy male and female subjects aged 18 to 60 years.

3. Have healthy skin over hands, with no inflammation or open wounds.

4. Able to understand, read and speak the German language.

5. Easy accessible veins on the dorsum of both hands.

Exclusion Criteria

1. Current significant active skin disease such as widespread eczema or active atopic dermatitis.

2. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI, to local anesthetics of the amide type or to any of the components of the EMLA emulsion (e.g., castor oil polyoxyl hydrogenated).

3. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI to chlorohexidine (preservative in the placebo patch emulsion).

4. Subjects who previously entered this study.

5. Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.

6. Judgement by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.

7. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. med.Rainard Fuhr

Role: PRINCIPAL_INVESTIGATOR

PAREXEL Early Phase Clinical Unit Berlin

Locations

Research Site

Berlin, , Germany

Countries

Germany

Other Identifiers

D069GC00001

Identifier Type: -

Identifier Source: org_study_id