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

NCT01360749 | Completed Phase 2

• 1 other identifier: ISD-LAM-2010-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Local Anesthesia

Keywords

Pain management; Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety assessments including AEs and SAEs

  48 hours after treatment

Study Arms (2)

Lambdalina and placebo

EXPERIMENTAL

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); Drug: Placebo

Placebo and lambdalina

EXPERIMENTAL

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); Drug: Placebo

Interventions

Lambdalina® (Lidocaine 4% cream) DRUG

Lambdaline dose: 2 g for 10 cm2.

Lambdalina and placebo; Placebo and lambdalina

Placebo DRUG

Placebo dose: 2 g for 10 cm2.

Lambdalina and placebo; Placebo and lambdalina

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ISDIN: lead

Study Sites (2)

Clínica Dermatológica Campo De Felipe

Barcelona, Spain

Location

Clínica Dermatológica Láser

Madrid, Spain

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Antonio Campo Voegeli, MD

  Clínica Dermatológica Campo De Felipe, Barcelona, Spain

  STUDY CHAIR

• Serafín Fernández, MD

  Clínica Dermatológica Láser, Madrid, Spain

  PRINCIPAL INVESTIGATOR

• Antonio Campo Voegeli, MD

  Clínica Dermatológica Campo De Felipe, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 26, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 13, 2012

Record last verified: 2012-04

Locations

ES (2)