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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01360749

Enrollment

Registered

2011-05-26

Start date

2011-05-31

Completion date

2011-11-30

Last updated

2012-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthesia

Keywords

Pain management, Lidocaine

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.

Interventions

DRUGLambdalina® (Lidocaine 4% cream)

Lambdaline dose: 2 g for 10 cm2.

DRUGPlacebo

Placebo dose: 2 g for 10 cm2.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Safety assessments including AEs and SAEs	48 hours after treatment

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026