Primary objectivesTo study the relation between the physiological, microbiological and immunological status of the skin and the response to an external stimulus; to assess:• the relations between microbiome and/or immunology and the skin type;• the…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study is explorative. The physiological, microbiological and immunological
features of the skin will be assessed at time points, before and after an
external stimulus to make comparisons between subjects with a sensitive and
insensitive skin by measurement of the blood perfusion, and taking microbiome
swab and biopsies (and additional tape stripping in study extension).
Adverse events, with emphasis on local skin irritation, will be recorded from
screening until the end of the study.
Secondary outcome
Not applicable
Background summary
In more recent years it has become apparent that the microbiological status of
the skin, the microbiome, may play a role in the homeostasis of the skin. The
cutaneous innate and adaptive immune responses were found to be able to
modulate the skin microbiota. In addition, the microbiota showed to have an
effect on the immune system. Although, the microbiome of the skin needs further
investigation to gain insight into microbial involvement in human skin
disorders [5] associations between immunological diseases of the skin and
population of the skin with certain bacterial strains, indicate that the
microbiome may play an important role in the response of the skin to internal
and external stimuli. Not much is known about the relationship between
microbiome composition and the inflammatory response to external or internal
stimuli.
Study objective
Primary objectives
To study the relation between the physiological, microbiological and
immunological status of the skin and the response to an external stimulus; to
assess:
• the relations between microbiome and/or immunology and the skin type;
• the relation between the response to an external stimulus and microbiome;
• the relation between the response to an external stimulus and immunology;
• the relation between physiological parameters and immunology of the skin in
response to an external stimulus;
• the relation between physiological parameters and microbiome of the skin in
response to an external stimulus.
Secondary objectives
To assess inter-individual differences in response of the skin in terms of
microbiology (microbiome) and immunology.
To design a model, describing the relationship between *the triangle* of skin
irritation (skin physiological changes), immunological changes and
microbiological changes.
To design a model to quantify inter-individual variations and identify
biomarker variables that describe relationships and possibly causes of skin
irritation given specific immunological and microbiological conditions.
Study design
This study has a controlled, open-treatment design.
The study consists of a screening, 1 study day of approximately 6 hours and two
additional visits of 30 minutes on Day 3 and Day 8 for subjects participating
in the study extension.
Study burden and risks
The risks associated with participation to this study are minimal. Obtaining
biopsies have a potential small risk of leaving a minimal scar.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
Inclusion criteria
1. Healthy male subjects, 18 to 65 years of age, inclusive;
2. Willing to undergo a shaving stimulus in the neck and upper leg;
3. Fitzpatrick skin type I-II-III-IV;
4. Last shave 24-36 hours prior to Day 1;
5. Used to electrical shaving;
Exclusion criteria
1. External use of isotretinoin within 3 months prior to or during this study, or oral use of isotretinoin (Accutane® or Roaccutance®) within 6 months prior to or during this study;
2. Coagulation problem or use of anticoagulation medicine, including the intensive use of Aspirin, where no wash-out period of at least 1 week is taken into consideration;
3. Use of corticosteroids within 2 weeks prior Day 1;
4. Use of an antihistamine within 1 month prior to Day 1;
5. Epilepsy, lupus erythematodes, -porphyria;
6. Collagen defect in the past, including keloid wound (keloid accumulation or keloid scar formation), history of bad wound healing;
7. History with vascular diseases, like varicose veins in the area of treatment;
8. History of immune disease (including HIV positively or AIDS), or an autoimmune disease, use of medicine for immune/autoimmune diseases;
9. Treatment of any form of cancer (lately or in the past), history of skin cancer or other form of cancer in the area of treatment, present pre-malignant lesions;
10. Bad skin conditions on the area of treatment (like infections, open wound, scrape) or any other form of inflammation of the skin;
11. Surgical intervention in the area of treatment within 3 months prior to this study;
12. Sunburn in the area of treatment within 1 week prior to the study;
13. Big birthmarks, port wine stains, or other pigmentations in the area of treatment (>1cm2).
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 | NL43920.056.13 |