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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023265
Enrollment
10
Registered
2020-10-13
Start date
2020-09-14
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R20.8 R21

Interventions

Group 1: 5-10 healthy human volunteers are subjected to the topical application of samples in order to further evaluate the skin irritation induced by the use of each product. The samples are applied
the assessment of skin irritation is conducted 20 minutes later on each area. The tests are carried out with a MultiProbe Adapter System from Courage&Khazaka Electronics (Koln, Germany), equipped with

Sponsors

Victor Babes University of Medicine and Pharmacy
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Human volunteers without skin lesions.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Romania

Contacts

Public ContactZoltan Dudas

Neutron Spectroscopy Department, Centre for Energy Research

dudas.zoltan@energia.mta.hu+36-1-392-2222 / 1849

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026