Skin Thickness Clinical Trial
Official title:
Echographic Measurement of Skin Thickness at the Deltoid and Proximal Forearm in Adults
Verified date | October 2015 |
Source | Novosanis NV |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Observational |
To optimize a medical device for intradermal injection, knowledge concerning the thickness
of epidermis and dermis at the proximal forearm is required. Since scientific knowledge is
lacking, the investigators will examine the skin thickness (epidermis and dermis) of adults
using imaging technology (High Frequency Ultrasound). The investigators hypothesize that
they are able to correlate the thickness of the (epi)dermis to a specific combination of
parameters age, gender, and BMI.
Based on these results, the investigators can define which needle type and length is needed
to correctly perform injections into the dermal layer.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Healthy adults - Age: 18-65 years - Dutch-speaking - Caucasian Exclusion Criteria: - Pregnancy or lactating - Using ointment, crème, or gels based on corticoids - Suffering from skin diseases (psoriasis, burning wounds) |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Belgium | Department of Pharmaceutical Sciences; Laboratory of Physiopharmacology; University of Antwerp; Campus Drie Eiken | Wilrijk | Antwerp |
Lead Sponsor | Collaborator |
---|---|
Novosanis NV |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | skin thickness (in milimeters) of the proximal forearm dorsal (both left and right) | 10 minutes | No | |
Primary | skin thickness (in milimeters) of the proximal forearm ventral (both left and right) | 10 minutes | No | |
Primary | skin thickness (in milimeters) of the deltoid region (both left and right) | 10 minutes | No | |
Secondary | Body Mass Index | at the moment of entering the study | No | |
Secondary | Age | at the moment of entering the study | No | |
Secondary | sex | at the moment of entering the study | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04540900 -
A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
|
Phase 1 | |
Completed |
NCT02727114 -
Echographic Measurement of Skin Thickness in Children
|
N/A |