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

ISDIN

Status and phase: Completed; Phase 2

Conditions: Local Anesthesia

Treatments: Drug: Lambdalina® (Lidocaine 4% cream); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01360749

ISD-LAM-2010-01

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Lambdalina and placebo

Experimental group

Description:

Eligible patients will receive lambdaline (lidocaine cream 40 mg/g) in Left Lower Extremity and placebo in Right Lower Extremity.

Treatment:

Drug: Placebo

Drug: Lambdalina® (Lidocaine 4% cream)

Placebo and lambdalina

Experimental group

Description:

Eligible patients will receive placebo in Left Lower Extremity and lambdaline (lidocaine cream 40 mg/g) in Right Lower Extremity.

Treatment:

Drug: Placebo

Drug: Lambdalina® (Lidocaine 4% cream)