In this project we would like to find out whether Sellotape stripped healthy skin can be used as an in vivo model for mechanical skin damage. This would contribute to more knowledge about growth, differentiation, inflammation and mechanical…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Parameters like amount of stratum corneum removal, epidermal thickness, influx
of inflammatory cells and vascularisation will be studied. Further, the
correlation between HE stained sections and RCM images will be investigated.
Secondary outcome
Not applicable
Background summary
Sellotape stripping is a commonly used standardized in vivo model for studying
skin barrier function, epidermal growth and concurrent immune responses. It is
not investigated whether this model can be used to study mechanical skin
damage. Studying this, would increase the knowledge about mechanical disruption
of the skin at biological and physiological level. In addition, this study
would contribute to develop of skin friendly materials. Currently used testing
methods, for example for testing artificial turf systems, do not simulate real
sport related skin damage in vivo. Therefore, a non-invasive in vivo model by
using RCM that simulates a real sport related injury would be of additional
value. Besides obtaining knowledge about growth, differentiation, inflammation,
pathology and damage of the skin, development of a non-invasive skin damage
model would contribute to development of skin friendly materials and prevents
biopsies in healthy volunteers in future research.
Study objective
In this project we would like to find out whether Sellotape stripped healthy
skin can be used as an in vivo model for mechanical skin damage. This would
contribute to more knowledge about growth, differentiation, inflammation and
mechanical disruption of the skin.
Study design
This study is an explorative observational (descriptive) study.
Study burden and risks
The study population consists of healthy volunteers, entering the study does
not lead to direct benefit for them. Before the volunteers will give informed
consent/assent, we will inform them that attending in this research is not in
any way beneficial to them. When the volunteer, despite of this, does wish to
attend in this study, most likely he/she will do this to make a contribution to
science. Considering this, we are of the opinion that a study with short
follow-up and only minimal invasive techniques, is legitimate. Tape stripping
and RCM imaging has been carried out by us in the past and has been proven to
be painless and without any discomfort. Punch biopsies are taken according to
standard procedures and may be slightly tender, scar formation does not occur
or is barely visible.
René Descartesdreef 1
6500 HB Nijmegen
NL
René Descartesdreef 1
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Adults between 18 and 65 years of age
Volunteers must be willing to give a written informed consent
Volunteers must be able to adhere to all requirements of the study
Volunteers must have skin type I, II or III, this will be evaluated together with a dermatologist
Exclusion criteria
Children or adolescents younger than 18 years of age
Volunteers with history or signs of chronic skin diseases
Volunteers with disturbed wound healing
Volunteers with relevant co-morbidities and medication
Volunteers exposed to large amounts of sunlight or UV-radiation in the last week
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40362.091.12 |