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Clinical Trials/NL-OMON38828
NL-OMON38828
Completed
Not 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 enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
skin irritation
Sponsor
TNO
Enrollment
30
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
TNO

Eligibility 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

  • 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;

Outcomes

Primary Outcomes

Not specified

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