Histamine-induced pruritus UVB-light-induced slight sunburn
Conditions
Interventions
Trade Name: Anaestherit 10% Salbe
Product Name: Anaesterit 10% Salbe
Pharmaceutical Form: Cutaneous spray, ointment
INN or Proposed INN: Benzocaine
CAS Number: 94-09-7
Other descriptive name: BENZOCAI
Sponsors
Dr. Ritsert Pharma
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Age: ? 18 and ? 45 years • Body Mass Index of 19.0 – 29.0 (kg/m2) • Male healthy subjects • Subject able and willing to sign informed consent • No antecedents of atopic, allergic or neurological disease within three months prior to the study • No skin lesions or scars on the tested area and around (within 5 cm from the tested area) • No use of cosmetics, ointment or cream on the studied areas from one week prior to the initiation of test • No anti-inflammatory drug within one week prior to the study • No anti-histamines within three weeks prior to the study • No systematic antiallergic medication 7 days prior to the study • No topical emollient preparation 14 days prior to the study • No topical or systemic steroids 1 months prior to the study • No psychopharmacological drugs 1 year prior to the study • Non-smoker (more than one year) • No intake of drugs known for inducing photosensitivity (e.g. Thioxanthenes (chlorprothixene, thiothixene), Antifungals, Itraconazole, Voriconazole, 5-Fluorouracil, Amiodarone, Diltiazem, Quinidine, Enalapril, Dapsone, Cinnamates, Salicylates) • No large-area tattoo or skin lesions (e.g. cicatrice) on forearms or upper back 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Unable to meet inclusion criteria. • Any concomitant illness or abnormal laboratory test which, in the investigator's opinion, would render the subject unsuitable for enrolment. • History of alcohol or drug abuse. • Known hypersensitivity to the product or excipients. • Other therapy that excludes the use of study treatment. • Participation in other clinical trials within the past 1 month. • Subjects with psoriasis, neurodermatitis or eczema. • Subjects treated with corticoids, cytotoxic drugs, cancer, HIV • The family of the investigators and the sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of Anaesthesin 10% Salbe in pain on skin;Secondary Objective: Evaluate the efficacy of Anaesthesin 10% Salbe in pruritus on skin;Primary end point(s): 1. The difference of VAS of itch between the administered sites, on which Anaestherit 10% or placebo was applied. 2. Measurement of pain using the Algometer FPX to determine the strength needed to induce pain. ;Timepoint(s) of evaluation of this end point: 1. after 1, 3, 6, 9, 12 and 30 min of application 2. before application, after 10, 20, 30 min and 1 and 6 hrs after application | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Difference of itch between the administered site, on which Anestherit 10% or placebo was applied by using the “Eppendorfer-Juckreizfragebogen” (part 1b). 2. The difference of VAS of pain between the administered sites, on which Anestherit 10% or placebo was applied. ;Timepoint(s) of evaluation of this end point: 1. after 1, 3, 6, 9, 12 and 30 min of application 2. before application, after 10, 20, 30 min and 1 and 6 hrs after application | — |
Countries
Austria
Contacts
Public ContactManaging Director
FORIM GmbH
Outcome results
None listed