Treatment of pruritus or uticaria
Conditions
Interventions
Product Name: PARENTIDE 0.5% Cream
Pharmaceutical Form: Cream
INN or Proposed INN: PARENTIDE
CAS Number: 1202877-06-2
Current Sponsor code: PAR
Other descriptive name: PAR
Concentration unit: mg/g mil
Sponsors
BCN Peptides
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antipruritic and antiinflamatory efficacy of two streghts of PARENTIDE cream in comparison with PLACEBO cream, after inducing itch and inflammation by the application of histamine on the human skin;Secondary Objective: - To evaluate the efficacy as antiinflamatory of two strenghts of PARENTIDE cream in comparison with PLACEBO cream, after inducing itch and inflammation by the application of histamine on the human skin - To evaluate the safety of two strenghts of PARENTIDE cream in comparison with PLACEBO cream, after inducing itch and inflammation by the application of histamine on the human skin - Determine if the topic application of PARENTIDE cream reaches the systemic circulation;Primary end point(s): Visual Analogic Scale (VAS) score for itch [0 = no itch; 10 = worst imaginable itch];Timepoint(s) of evaluation of this end point: Itch will be evaluated at times 2, 5, 10, 20, 30, 45 and 60 minutes after the skin prick test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Registration of the adverse events of the subjects after the application of the products under investigation and evaluation of their intensity, causality and frequency. - Erythema index - Temperature. - Diameter (mm) of the irritated area. - Diameter (mm) of the wheal (wheal).;Timepoint(s) of evaluation of this end point: Erythema index and temperature basal values will be recorded at time -5 min before the treatment. After treatment, there will be recorded a times 2, 5, 10, 20, 30, 45 and 60 minutes after the application of the skin prick test. Diameters of the irritated area and wheal will be registered at times times 2, 5, 10, 20, 30, 45 and 60 minutes after the application of the skin prick test. Adverse events will be registered at any time of their outcome and they will be monitored until their resolution. | — |
Countries
Spain
Contacts
Public ContactR&D Preclinical and Clinical Dept.
BCN Peptides
Outcome results
None listed