A Study to Assess Therapeutic Equivalence Between Test EMLA Patch With Marketed EMLA Patch in Healthy Subjects.
Condition: Pain
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): EMLA test patch; EMLA current reference patch; Placebo Patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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 MeSH terms: Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model 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 visual analogue scale (VAS). 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.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Dermal anesthesia.; Venipuncture and intravenous cannulation.; Skin blanching or erythema.; Phase I.; Therapeutic equivalence.; Eutectic Mixture of Local anaesthetics (EMLA)