Double-blind, randomized clinical study to determine the efficacy of Anestherit® 10% on histamine-induced pruritus and UVB-light induced slight sunburn in healthy subjects.

Dr. Ritsert Pharma0 个研究点开始时间: 2012年8月13日最近更新: 2013年3月4日

适应症

试验速览

暂无简介。

•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.

发起方

Dr. Ritsert Pharma