A randomized, double blinded, placebo controlled clinical trial to evaluate the antipruritic efficacy of the topical application of PARENTIDE cream in histamine-induced itch in healthy volunteers - PARENTIDE cream for the treatment of pruritus

BCN Peptides0 个研究点目标入组 45 人开始时间: 2022年5月12日最近更新: 2023年9月26日

试验速览

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•- Healthy volunteers between 18 and 60 years (included) at the moment of the signature of the Informed Consent.
•- Volunteers with moderate to severe cutaneous reaction according to VAS (Visual Analogic Scale) reported between 4 and 8, 2 minutes after the induction in the control area at Visit 1.
•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 45
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Pregnancy or breastfeeding.
•- Consumption of cannabis, opioids or other drugs in the last month.
•- Positive urine drug test.
•- History of neurological, musculoskeletal or mental illness or currently presenting one of these illnesses.
•- Lack of availability to participate.
•- Concomitant use of medication that may affect the trial, such as antihistamines, antipsychotics and analgesics, as well as systemic or topical steroid treatment.
•- Consumption of alcohol or analgesics in the last 72 hours before the study and during the study.
•- Scars or tattoos in the study area.
•- Acute or chronic pain.
•- Allergy, hypersensitivity or any other type of incompatibility with any of the components of the investigational products.
•- Participation in another study in the week prior to the study or in the last 4 weeks in the case of clinical trials with drugs.
•- Other conditions or situations that may put the subject at significant risk, that may confound the results of the study, or that may significantly interfere with the participation of patients in the study.

发起方

BCN Peptides