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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ISDIN
ClinicalTrials.gov Identifier:
NCT01360749
First received: May 24, 2011
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Local Anesthesia
Drug: Lambdalina® (Lidocaine 4% cream)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre, Double-Blind Trial to Evaluate the Efficacy and Safety of Lambdalina vs Placebo as an Anesthetic for Laser Hair Removal

Resource links provided by NLM:


Further study details as provided by ISDIN:

Primary Outcome Measures:
  • 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) [ Time Frame: 30 minutes after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessments including AEs and SAEs [ Time Frame: 48 hours after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: May 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360749

Locations
Spain
Clínica Dermatológica Campo De Felipe
Barcelona, Spain
Clínica Dermatológica Láser
Madrid, Spain
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: ISDIN
ClinicalTrials.gov Identifier: NCT01360749     History of Changes
Other Study ID Numbers: ISD-LAM-2010-01
Study First Received: May 24, 2011
Last Updated: April 12, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by ISDIN:
Pain management
Lidocaine

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014