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

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

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

Study Overview

• Status: Completed
• Conditions: Local Anesthesia
• Intervention / Treatment: Drug: Lambdalina® (Lidocaine 4% cream); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Clínica Dermatológica Campo De Felipe
  • Madrid, Spain
    • Clínica Dermatológica Láser

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women ≥ 18 and ≤ 65 years old.
2. Laser hair removal treatment session in the legs in the area from the knee to the ankle (first or second application).
3. Able of accomplishing the study's requirements.
4. Negative result in the pregnancy test.
5. Sterile or surgically sterilized women (hysterectomy, tubal ligation) or using adequate contraceptive methods.
6. Written informed consent prior to inclusion in the trial.

Exclusion Criteria:

- General exclusion criteria:

1. Pregnant or breastfeeding.

   - Current or previous medical conditions:

2. Skin type 5 or 6 or a history of photosensitivity.
3. Cardiovascular diseases such as unstable angina, or severe heart failure (New York Heart Association III or IV).
4. Neuropathy or paresthesia.
5. History of hepatic failure.
6. Autoimmune diseases.
7. Allergies to peanuts and/or soy and/or any components of the formulation.
8. Use or dependence on prohibited substances.

9. Other contraindications specified in the summary of product characteristics.

   - Current or previous concomitant medications:

10. Any anesthetic or analgesic treatment during 2 hours prior of study entry.
11. 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.
12. Active wounds or irritations in the area to be treated.
13. Topical treatment with corticosteroids or other topical agent in the area to be studied.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lambdalina and placebo; 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); Lambdaline dose: 2 g for 10 cm2.; Drug: Placebo; Placebo dose: 2 g for 10 cm2.
Experimental: Placebo and lambdalina; 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); Lambdaline dose: 2 g for 10 cm2.; Drug: Placebo; Placebo dose: 2 g for 10 cm2.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ISDIN
• Investigators: Study Chair: Antonio Campo Voegeli, MD, Clínica Dermatológica Campo De Felipe, Barcelona, Spain; Principal Investigator: Serafín Fernández, MD, Clínica Dermatológica Láser, Madrid, Spain; Principal Investigator: Antonio Campo Voegeli, MD, Clínica Dermatológica Campo De Felipe, Barcelona, Spain

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 24, 2011
• First Submitted That Met QC Criteria: May 25, 2011
• First Posted (Estimate): May 26, 2011

Study Record Updates

• Last Update Posted (Estimate): April 13, 2012
• Last Update Submitted That Met QC Criteria: April 12, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Pain management; Lidocaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: ISD-LAM-2010-01