A Study to Assess Therapeutic Equivalence Between Test EMLA Patch With Marketed EMLA Patch in Healthy Subjects. (EMLA)
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|ClinicalTrials.gov Identifier: NCT03313336|
Recruitment Status : Completed
First Posted : October 18, 2017
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: EMLA test patch Drug: EMLA current reference patch Drug: Placebo Patch||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|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|
|Official Title:||A Double-blind, Randomized, 2-period, Placebo-controlled, Single-center, Crossover Study to Assess the Therapeutic Equivalence of the EMLA Current Reference Patch and the EMLA Test Patch in Healthy Subjects.|
|Actual Study Start Date :||October 30, 2017|
|Actual Primary Completion Date :||November 9, 2017|
|Actual Study Completion Date :||November 9, 2017|
Active Comparator: Cohort 1
EMLA Test Patch.
Drug: 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.
Active Comparator: Cohort 2
EMLA Reference Patch.
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.
Placebo Comparator: Cohort 3
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.
- Comparison of anesthetic efficacy of EMLA Test Patch with the marketed EMLA patch (EMLA current Reference Patch) by pain reduction assessment. [ Time Frame: At test procedure 1 and at test procedure 2 (which is after 4 days of washout period following test procedure 1). ]To compare the anesthetic efficacy in pain reduction after an intravenous needle insertion whether or not actual IV insertion was achieved will be evaluated by visual analogue scale (VAS). The degree of pain experienced will be assessed on a 100 mm horizontal, non-graded paper-based VAS, with the endpoints representing "no pain" (0 mm), to "the worst possible pain" (100 mm). The VAS scores will be listed by subject, treatment sequence (TP/TR and TR/TP, where T=test, R=reference and P=Placebo), treatment (T, R and P) and hand (left, right).
- Number of participants with Adverse events (AEs), skin sensation and reactions as variables of safety and tolerability. [ Time Frame: From randomization until test procedure 2 or last study visit, whichever is later. ]AEs will be collected from the start of randomization throughout the treatment period up to and including the Follow-up Visit. Any AE that is ongoing at the last visit will be followed up as appropriate. Serious AEs will be recorded from the time of informed consent. Local skin sensations will be assessed by asking about injection site sensations (sensation experienced before removal of the patch), this will be rated on a four-point scale: none, mild, moderate or severe. Skin reactions will be performed after removal of the patch to inspect the area which has been in contact with the cream and the patch. Two separate assessments will be made - one for the skin in contact with the cream and one for the skin which had been in contact with the adhesive border.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313336
|Berlin, Germany, 14050|
|Principal Investigator:||Dr. med.Rainard Fuhr||PAREXEL Early Phase Clinical Unit Berlin|