A study to investigate the efficacy of PARENTIDE cream, a new drug for the treatment of itch

Phase 1

• Conditions: Treatment of pruritus or uticaria; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2022-001374-60-ES
• Lead Sponsor: BCN Peptides

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-12
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified