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

Phase 2

Completed

• Conditions: Local Anesthesia
• Interventions: Drug: Lambdalina® (Lidocaine 4% cream); Drug: Placebo

• Registration Number: NCT01360749
• Lead Sponsor: ISDIN

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-26
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-12
• Last Update Posted: 2012-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lambdalina and placebo	Lambdalina® (Lidocaine 4% cream)	Eligible patients will receive lambdaline (lidocaine cream 40 mg/g) in Left Lower Extremity and placebo in Right Lower Extremity.
Lambdalina and placebo	Placebo	Eligible patients will receive lambdaline (lidocaine cream 40 mg/g) in Left Lower Extremity and placebo in Right Lower Extremity.
Placebo and lambdalina	Lambdalina® (Lidocaine 4% cream)	Eligible patients will receive placebo in Left Lower Extremity and lambdaline (lidocaine cream 40 mg/g) in Right Lower Extremity.
Placebo and lambdalina	Placebo	Eligible patients will receive placebo in Left Lower Extremity and lambdaline (lidocaine cream 40 mg/g) in Right Lower Extremity.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety assessments including AEs and SAEs	48 hours after treatment

Trial Locations

Locations (2)

Clínica Dermatológica Campo De Felipe; 🇪🇸 Barcelona, Spain

Clínica Dermatológica Láser; 🇪🇸 Madrid, Spain