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Double-blind, randomized, placebo-controlled trial to assess the efficacy of Lambdalina (lidocaine cream) in reducing pain associated with laser hair removal in women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lambdalina and placebo | Experimental | Eligible patients will receive lambdaline (lidocaine cream 40 mg/g) in Left Lower Extremity and placebo in Right Lower Extremity. |
|
| Placebo and lambdalina | Experimental | Eligible patients will receive placebo in Left Lower Extremity and lambdaline (lidocaine cream 40 mg/g) in Right Lower Extremity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lambdalina® (Lidocaine 4% cream) | Drug | Lambdaline dose: 2 g for 10 cm2. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments including AEs and SAEs | 48 hours after treatment |
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Inclusion Criteria:
Exclusion Criteria:
- General exclusion criteria:
Pregnant or breastfeeding.
- Current or previous medical conditions:
Skin type 5 or 6 or a history of photosensitivity.
Cardiovascular diseases such as unstable angina, or severe heart failure (New York Heart Association III or IV).
Neuropathy or paresthesia.
History of hepatic failure.
Autoimmune diseases.
Allergies to peanuts and/or soy and/or any components of the formulation.
Use or dependence on prohibited substances.
Other contraindications specified in the summary of product characteristics.
- Current or previous concomitant medications:
Any anesthetic or analgesic treatment during 2 hours prior of study entry.
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.
Active wounds or irritations in the area to be treated.
Topical treatment with corticosteroids or other topical agent in the area to be studied.
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Campo Voegeli, MD | ClÃnica Dermatológica Campo De Felipe, Barcelona, Spain | Study Chair |
| SerafÃn Fernández, MD | ClÃnica Dermatológica Láser, Madrid, Spain | Principal Investigator |
| Antonio Campo Voegeli, MD | ClÃnica Dermatológica Campo De Felipe, Barcelona, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Dermatológica Campo De Felipe | Barcelona | Spain | ||||
| ClÃnica Dermatológica Láser |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | Placebo dose: 2 g for 10 cm2. |
|
| Madrid |
| Spain |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |