Efficacy and Safety of Lambdalina (Lidocaine Cream) Versus Placebo as an Anesthetic for Laser Hair Removal

Study Overview
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Brief Summary
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Double-blind, randomized, placebo-controlled trial to assess the efficacy of Lambdalina (lidocaine cream) in reducing pain associated with laser hair removal in women.

Official Title
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Multicentre, Double-Blind Trial to Evaluate the Efficacy and Safety of Lambdalina vs Placebo as an Anesthetic for Laser Hair Removal

Conditions
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Local Anesthesia

Intervention / Treatment
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* Drug: Lambdalina® (Lidocaine 4% cream)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ≥ 18 and ≤ 65 years old. Laser hair removal treatment session in the legs in the area from the knee to the ankle (first or second application). Able of accomplishing the study's requirements. Negative result in the pregnancy test. Sterile or surgically sterilized women (hysterectomy, tubal ligation) or using adequate contraceptive methods. Written informed consent prior to inclusion in the trial. Exclusion Criteria: - General exclusion criteria: Pregnant or breastfeeding. - Current or previous medical conditions: Skin type 5 or 6 or a history of photosensitivity. Cardiovascular diseases such as unstable angina, or severe heart failure (New York Heart Association III or IV). Neuropathy or paresthesia. History of hepatic failure. Autoimmune diseases. Allergies to peanuts and/or soy and/or any components of the formulation. Use or dependence on prohibited substances. Other contraindications specified in the summary of product characteristics. - Current or previous concomitant medications: Any anesthetic or analgesic treatment during 2 hours prior of study entry. Concomitant treatment with antiarrhythmic drugs of class I (eg. tocainide, mexiletine) or class III (eg. amiodarone, sotalol), anticoagulants, anti-platelet aggregating and/or beta-blockers. Active wounds or irritations in the area to be treated. Topical treatment with corticosteroids or other topical agent in the area to be studied.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lambdalina and placebo<br>Eligible patients will receive lambdaline (lidocaine cream 40 mg/g) in Left Lower Extremity and placebo in Right Lower Extremity. | Drug: Lambdalina® (Lidocaine 4% cream)<br>* Lambdaline dose: 2 g for 10 cm2.<br>Drug: Placebo<br>* Placebo dose: 2 g for 10 cm2.<br>|
| Experimental: Placebo and lambdalina<br>Eligible patients will receive placebo in Left Lower Extremity and lambdaline (lidocaine cream 40 mg/g) in Right Lower Extremity. | Drug: Lambdalina® (Lidocaine 4% cream)<br>* Lambdaline dose: 2 g for 10 cm2.<br>Drug: Placebo<br>* Placebo dose: 2 g for 10 cm2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in pain intensity (Pain Visual Analogue Scale) associated to laser hair removal from baseline to the end of laser hair removal session (primary endpoint) |  | 30 minutes after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments including AEs and SAEs |  | 48 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain management, Lidocaine