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

Local Anesthesia Clinical Trial

Official title:

Multicentre, Double-Blind Trial to Evaluate the Efficacy and Safety of Lambdalina vs Placebo as an Anesthetic for Laser Hair Removal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360749
• Other study ID #: ISD-LAM-2010-01
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2011
• Last updated: April 12, 2012
• Start date: May 2011
• Est. completion date: November 2011

Study information

• Verified date: April 2012
• Source: ISDIN
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Local Anesthesia

Intervention

Drug:
• Lambdalina® (Lidocaine 4% cream)
Lambdaline dose: 2 g for 10 cm2.
• Placebo
Placebo dose: 2 g for 10 cm2.

Locations

Country	Name	City	State
Spain	Clínica Dermatológica Campo De Felipe	Barcelona
Spain	Clínica Dermatológica Láser	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
ISDIN

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety assessments including AEs and SAEs		48 hours after treatment	Yes