Healthy volunteers
Conditions
Interventions
Group 1: Each subject will have nine test sites, four on the left thigh, four on the right thigh (resulting in 8 test sites on both thighs) and one on the arm. Each of the nine test site will have 2 d
Sponsors
HEALTH – Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Ges.mbH,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 18 to 65 years inclusive, Males and/or non-pregnant, non-breastfeeding females (subjects need to be informed about adequate contraceptive methods). Able to read, understand, and sign the written informed consent form. Willing to follow the protocol requirements and comply with protocol restrictions.
Exclusion criteria
Exclusion criteria: Smoker who is not willing to restrain from smoking during the in-house-visit (Visit 2). History of drug and/or alcohol abuse within one year of start of study as judged by the investigator. Tattoos or broken and/or damaged skin at the application areas. Active skin diseases like psoriasis or atopic dermatitis. Not willing to avoid excessive sun exposure, steam baths, sauna, swimming and other strenuous activities between Visit 2 and the End-of-Study examination Not willing to refrain from shaving the anterior of the thighs or using skin care products on the anterior of the thighs for at least 5 days prior to start of Visit 2. Pronounced hairiness on the thighs that may negatively affect BE testing. Known allergy/hypersensitivity to any of the materials/supplies used during the study. Presence of needle phobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lidocaine/ prilocaine concentration-time curves for the ISF samples obtained from the test sites dosed with three different doses of EMLA® cream. Area under the lidocaine/ prilocaine concentration-time curve from 0-24 hours (AUC0-24) for the ISF samples obtained from the test sites dosed with EMLA® cream. Maximum observed lidocaine/prilocaine concentration (Cmax) in the ISF samples obtained from the test sites dosed with EMLA® cream. Time to reach maximum lidocaine/prilocaine concentration (TMAX) in the ISF samples obtained from the test sites dosed with EMLA® cream. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lidocaine/ prilocaine concentration-time curves for the ISF samples obtained from the test sites dosed with of EMLA® cream, with ORAQIX® gel and with no product application. Lidocaine/ prilocaine concentration-time curves for the blood samples. Area under the lidocaine/ prilocaine concentration-time curve from 0-24 hours (AUC0-24) for the ISF samples obtained from the test sites dosed with EMLA® cream, with ORAQIX® gel and with no product application. Maximum observed lidocaine/prilocaine concentration (Cmax) in the ISF samples obtained from the test sites dosed with EMLA® cream, with ORAQIX® gel and with no product application. Time to reach maximum lidocaine/prilocaine concentration (TMAX) in the ISF samples obtained from the test sites dosed with EMLA® cream, with ORAQIX® gel and with no product application. Factors influence skin penetration (e.g. TEWL, impedance). Inflammation marker and immune cell content | — |
Countries
Austria
Contacts
Public ContactGerd Schwagerle
Clinical Research Center, Medizinische Universität Graz
Outcome results
None listed