skin irritation
Conditions
Interventions
None listed
Sponsors
TNO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed