Design and preliminary characterisation of a drug delivery system based on polyurethane particles

Phase 1

• Conditions: R20.8; R21; Other and unspecified disturbances of skin sensation; Rash and other nonspecific skin eruption

• Registration Number: DRKS00023265
• Lead Sponsor: Victor Babes University of Medicine and Pharmacy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-13
• Study Completion: 2021-07-30
• Results First Posted: 2022-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Human volunteers without skin lesions.

Exclusion Criteria

1. Subjects with systemic disorders, atopic dermatitis, eczema, psoriasis
2. Subjects with a condition or receiving a medication and/or with a history of medical/surgical events which, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study
3. Subjects with a history of skin cancer

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A MultiProbe Adapter System from Courage&Khazaka Electronics (Koln, Germany), equipped with a Tewameter® TM300 probe and a Mexameter® MX18 probe will be used to measure the changes of transepidermal water loss and erythema for 15 days (sample applications and skin evaluations every third day).

Secondary Outcome Measures

Name	Time	Method
The evaluations period is 15 days. Data will be analysed using single-ANOVA and compared with the references from scientific literature.