title: A noninvasive method to assess skin irritation and compromised skin conditions using simple tape adsorption of molecular markers of inflammation.
abstract: OBJECTIVE
  We have developed a simple noninvasive method to assess inflammatory changes in human skin, even in the absence of visible clinical irritation. Our approach is based on a simple tape (Sebutape) adsorption method to recover molecular mediators of skin inflammation (e.g., cytokines). This procedure has been used to investigate baseline cytokine levels on skin, to assess normal skin condition and to evaluate changes due to chemical insult, existing dermatitis, or sun exposure.
  
  
  METHODS
  In clinical studies, Sebutape was applied to normal appearing uncompromised skin, as well as to compromised (diaper or heat rash), chemically treated (sodium laurel sulfate), or sun-exposed skin. Sebutape was applied to the skin for a 1 min collection interval. Tapes were extracted in saline using a 10 min sonication, and the extracts were analyzed for human interleukin-1alpha (IL-1alpha), IL-1 receptor antagonist (IL-1RA) and IL-8 using commercial immunoassay test kits. The cytokine levels recovered from each tape extract were normalized to total protein (TP) levels. In infant product use tests, the severity of skin irritation (diaper and heat rash or erythema) was also assessed using a visual grading scale.
  
  
  RESULTS
  The method itself caused minimal, if any, skin damage. Additionally, Sebutape was shown to quantitatively adsorb detectable levels of cytokine from normal-appearing (control) or compromised (e.g., rashed or chemically treated) skin. In infant studies, significant increases in IL-1alpha levels were found in skin exhibiting diaper rash, heat rash and erythema compared with normal appearing control skin sites. When these results were normalized to total protein levels recovered from each tape, the significance was maintained. A positive correlation (r2=0.82) existed between IL-1RA levels and diaper rash severity. Significant increases in IL-8 levels were recovered from diaper rash versus control skin sites. There were differences in baseline cytokine levels in normal skin related to body site and sun exposure. The IL-1 RA/IL-1alpha ratios for sun-exposed skin of the face and lower leg were significantly (P<0.05) higher (3-6-fold) than those for skin sites that typically receive minimal sun exposure (i.e., underarm, upper leg and upper back). There was a significant increase in IL-1alpha and a directional increase in IL-8 levels in adult skin sites treated with the irritant, sodium lauryl sulfate, even in the absence of visible skin irritation (erythema).
  
  
  CONCLUSIONS
  Our results demonstrate that this method is a useful noninvasive technique for assessing skin inflammatory events. In addition, the method is simple and easily applied in a clinical setting, whether on infants or adults.
authors.affiliation: The Procter & Gamble Company, Human & Environmental Safety Division, Miami Valley Laboratories, Cincinnati, Ohio 45253-8707, USA. PERKINS.MA@PG.COM
authors.forename: M A
authors.initials: MA
authors.lastname: Perkins
authors.forename: M A
authors.initials: MA
authors.lastname: Osterhues
authors.forename: M A
authors.initials: MA
authors.lastname: Farage
authors.forename: M K
authors.initials: MK
authors.lastname: Robinson
mesh_terms: D000269:Adhesives; D000327:Adsorption; D000368:Aged; D015415:Biomarkers; D016207:Cytokines / Q000378:metabolism; D003872:Dermatitis / Q000175:diagnosis* / Q000378:metabolism*; D004781:Environmental Exposure; D005542:Forearm; D006801:Humans; D007223:Infant; D053590:Interleukin 1 Receptor Antagonist Protein; D007375:Interleukin-1 / Q000378:metabolism; D016209:Interleukin-8 / Q000378:metabolism; D012795:Sialoglycoproteins / Q000378:metabolism; D012867:Skin / Q000187:drug effects / Q000378:metabolism / Q000528:radiation effects; D012871:Skin Diseases / Q000175:diagnosis* / Q000378:metabolism*; D012967:Sodium Dodecyl Sulfate / Q000494:pharmacology; D013472:Sunlight; D013501:Surface-Active Agents / Q000494:pharmacology; D013997:Time Factors
chemical_list: D000269:Adhesives; D015415:Biomarkers; D016207:Cytokines; C507763:IL1RN protein, human; D053590:Interleukin 1 Receptor Antagonist Protein; D007375:Interleukin-1; D016209:Interleukin-8; D012795:Sialoglycoproteins; D013501:Surface-Active Agents; D012967:Sodium Dodecyl Sulfate