Clinical study to determine the efficacy of Anaestherit 10% when applied on pruritus (induced via Histamine injection) or slight sunburn (induced via UVB-light).
- Conditions
- Histamine-induced pruritusUVB-light-induced slight sunburnTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2012-002835-27-AT
- Lead Sponsor
- Dr. Ritsert Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
•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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br><br>2. Measurement of pain using the Algometer FPX to determine the strength needed to induce pain.<br>;Timepoint(s) of evaluation of this end point: 1. after 1, 3, 6, 9, 12 and 30 min of application<br><br>2. before application, after 10, 20, 30 min and 1 and 6 hrs after application
- Secondary Outcome Measures
Name Time Method 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). <br><br>2. The difference of VAS of pain between the administered sites, on which Anestherit 10% or placebo was applied. <br>;Timepoint(s) of evaluation of this end point: 1. after 1, 3, 6, 9, 12 and 30 min of application<br><br>2. before application, after 10, 20, 30 min and 1 and 6 hrs after application