A study to demonstrate the effect of topical anesthetics Lidocaine and Prilocaine cream in subject undergoing cannulation for blood investigation.

Phase 3

Completed

Conditions: Healthy Volunteers

Registration Number: CTRI/2023/10/058420

Lead Sponsor: Gracure Pharmaceuticals Ltd.

Brief Summary: This study will be conducted to demonstrate the therapeutic non-inferiority of Lidocaine 2.5% and Prilocaine 2.5% cream (test product) to reference product EMLA 5% (Lidocaine 25 mg/g and Prilocaine 25 mg/g) cream in subjects undergoing forearm cannulation. Sufficient number of subjects will be enrolled in the study to get 60 evaluable subjects. Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study. Subjectâ€™s visit will be screening visit followed by randomization visit. Crossover visit will be on day 7 and day 14. Subjects will be screened for the eligibility criteria during screening visit.

Subjects will be instructed to apply 2 g of cream approximately half of 5 g tube in a form of thick layer to the skin without rubbing, under an occlusive dressing to both forearms (dorsum hand) for a period of 2 hours for 14 days. Subjects will be randomized in three groups: test, reference and placebo. The primary endpoint will be change in pain score based on VAS score from baseline and the secondary end point will be treatment emergent adverse events and assessment of local tolerability (after 5 min and 30 min after cannula removal).

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 66

Inclusion Criteria

Male or female between 18 to 65 years of age (both inclusive).
Subject who found peripheral venous cannulation painful (define as a pain recording of 25mm or greater on a 100 mm VAS for pain) without local anaesthetic.
The subject is willing to complete all the study procedures including study-related tasks, and comply with the study requirements.
Subject with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.

Exclusion Criteria

1.Subject with mental illness.
2.Known allergy or sensitivity to local anesthetics or hypersensitivity to lidocaine and/or prilocaine or local anaesthetics of the amide type or to any of the excipients.
3.Damaged or inflamed skin or open wounds at the designated application site.
4.Use of analgesics during the past 24 hours.
5.Participation in any other study during last 1 month.
6.Suspected lack of compliance with any requirements of the study.
7.Any relevant abnormalities in the routine laboratory tests.
10.Uncommunicative/deaf/mute subject.
11.Subject on hypnotics, or chronic pain relief medications.
13.Subjects with atopic dermatitis 14.Subject who are on CYP450 3A4, 3A5 or 1A2-inducing or inhibiting drugs (erythromycin, ciprofloxacin, amiodarone etc.) or pharmacotherapeutic agents that affect hepatic blood flow (metoprolol) since both may affect the metabolism of lidocaine.
15.Subjects with defective glucose-6-phosphate dehydrogenase, hereditary or idiopathic methaemoglobinaemia.
16.Subjects treated with anti-arrhythmics of class III (e.g., amiodarone), methaemoglobin-inducing medicinal products (e.g. sulphonamides, nitrofurantoin, phenytoin, phenobarbital), medicinal products that reduce the clearance of lidocaine (e.g., cimetidine or betablockers).
17.Subjects with Class I antiarrhythmic drugs (such as tocainide and mexiletine) which can have additive and potentially synergistic toxic effects.
18.Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pain score based on VAS score from baseline	Day 1, Day 7, Day 14

Secondary Outcome Measures

Name	Time	Method
â€¢Treatment Emergent Adverse events (TEAEs)	â€¢Assessment of local tolerability (after 5 min & 30 min after cannula removal)

Trial Locations

Locations (1): Prajna Healthcare Center
🇮🇳
Ahmadabad, GUJARAT, India
Prajna Healthcare Center
🇮🇳Ahmadabad, GUJARAT, India
Dr Pragati Trivedi
Principal investigator
9265472125
phc.clinicaltrials@gmail.com