Algesia in healthy subjects during mechanical epilation
Conditions
Interventions
Trade Name: Emla Creme
Pharmaceutical Form: Cream
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-6
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 25-
INN
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female adult volunteers 18-35 years • The volunteers must have a coat in the depilated area of at least 2 mm. • Test 1, 2: These tests should be performed with women, who regularly use a wet or dry razor. (Last shave about 2 weeks) • Test 3: This test may be performed by women, who regularly use a razor (Last shave about 2 weeks) as well as by woman who prefer the epilation with wax (last 4 weeks), respectively. • Personally signed and dated informed consent form before any test-specific measure is performed. • Subject is able to give consent. • Subject is able to understand type, scope and consequences of the clinical trial. • Subject is able to document its written consent to the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • serious underlying diseases, especially those of the immune system (eg HIV infection, hepatitis infection) • cancer • epilepsy • pregnancy or lactating woman • simultaneous UV-irradiation on the day of depilation • antihistamines • treatment with corticosteroids or drugs that influence algesia up to 48 hours prior to the epilation (internally or topically) • bleeding disorders, existing anticoagulant therapy (eg warfarin) • known hypersensitivity to the substances to be applied and / or disinfectants • hypersensitivity to the investigational product or a chemically similar substance or the components of a / the investigational / s products • participation in other clinical trials during or within 3 months prior to this trial. • medical or psychological circumstances that may endanger the proper conduct of the trial. • menstruation at the time of epilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the algesia after application of Emla cream or polidocanol cream versus placebo during the mechanical epilation.;Secondary Objective: Investigation of Cold-and Pressure-sensitivity of the subjects before and after exposure to the investigational products Safety and tolerability of the application;Primary end point(s): The primary endpoint is the evaluation of algesia measured by visual analog scale (VAS) during epilation. | — |
Countries
Germany
Outcome results
None listed