Clinical trial NCT01360749: Efficacy and Safety of Lambdalina (Lidocaine Cream) Versus Placebo as an Anesthetic for Laser Hair Removal
Official title: Multicentre, Double-Blind Trial to Evaluate the Efficacy and Safety of Lambdalina vs Placebo as an Anesthetic for Laser Hair Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Local Anesthesia
Keywords: Pain management
Lidocaine
Lead sponsor: ISDIN
Sponsor class: INDUSTRY
First posted: 2011-05-26
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: 30 minutes after treatment
Secondary outcomes:
measure: Safety assessments including AEs and SAEs
timeFrame: 48 hours after treatment
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clínica Dermatológica Campo De Felipe
city: Madrid
country: Spain
facility: Clínica Dermatológica Láser
Study officials:
affiliation: Clínica Dermatológica Campo De Felipe, Barcelona, Spain
name: Antonio Campo Voegeli, MD
role: STUDY_CHAIR
affiliation: Clínica Dermatológica Láser, Madrid, Spain
name: Serafín Fernández, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Dermatológica Campo De Felipe, Barcelona, Spain
name: Antonio Campo Voegeli, MD
role: PRINCIPAL_INVESTIGATOR
References: