Overview
Efficacy and Safety of Lambdalina (Lidocaine Cream) Versus Placebo as an Anesthetic for Laser Hair Removal
Status:
Completed
Completed
Trial end date:
2011-11-01
2011-11-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
ISDINTreatments:
Anesthetics
Lidocaine
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.