A study of biological, immunological and physiological parameters describing skin irritation induced by a physical stimulus in healthy male volunteers

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study is explorative. The physiological, microbiological and immunological<br /><br>features of the skin will be assessed at time points, before and after an<br /><br>external stimulus to make comparisons between subjects with a sensitive and<br /><br>insensitive skin by measurement of the blood perfusion, and taking microbiome<br /><br>swab and biopsies (and additional tape stripping in study extension).<br /><br><br /><br>Adverse events, with emphasis on local skin irritation, will be recorded from<br /><br>screening until the end of the study. </p><br>

Secondary Outcome Measures