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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-11-30

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.

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Detailed Description

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Conditions

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Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lambdalina and placebo

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

Group Type EXPERIMENTAL

Lambdalina® (Lidocaine 4% cream)

Intervention Type DRUG

Lambdaline dose: 2 g for 10 cm2.

Placebo

Intervention Type DRUG

Placebo dose: 2 g for 10 cm2.

Placebo and lambdalina

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

Group Type EXPERIMENTAL

Lambdalina® (Lidocaine 4% cream)

Intervention Type DRUG

Lambdaline dose: 2 g for 10 cm2.

Placebo

Intervention Type DRUG

Placebo dose: 2 g for 10 cm2.

Interventions

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Lambdalina® (Lidocaine 4% cream)

Lambdaline dose: 2 g for 10 cm2.

Intervention Type DRUG

Placebo

Placebo dose: 2 g for 10 cm2.

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes