NL-OMON38828CompletedNot Applicable
A study of biological, immunological and physiological parameters describing skin irritation induced by a physical stimulus in healthy male volunteers - Skin irritation induced by a physical stimulus
TNO0 sites30 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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).
Investigators
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