title: Optimisation of a dosing regime for a topical skin protectant (barrier cream).
abstract: BACKGROUND
  Topical skin protectants (barrier creams) have the potential to reduce or enhance the severity of dermal lesions following exposure to allergens or irritants. Therefore, it is essential that such products are subject to appropriate clinical evaluation prior to marketing. Consequently, it is important to accurately define a dosing regime in order to assess test products under appropriate conditions.
  
  
  OBJECTIVE
  In this study, we extended the use of a standard rubefacient (methyl nicotinate; MN) assay to establish the optimum thickness and duration of action of a novel barrier cream (RD1433). White petroleum jelly (Vaseline(®)) was used as a comparator product.
  
  
  METHODS
  The dermal response to MN was measured on the volar forearm skin of volunteers (n = 12; average age 47.5 years) using an array of biophysical instruments and visual scoring. When applied at a nominal thickness of 0.1 mm, RD1433 retained effectiveness against MN for up to six hours. In contrast, Vaseline(®) was relatively ineffective. Moreover, RD1433 provoked no measurable signs of irritation and so can be considered acceptable for further clinical evaluation.
  
  
  CONCLUSIONS
  Future clinical studies using RD1433 should be based on topical application of a 0.1 mm thickness layer every six hours.
authors.affiliation: a Department of Pharmacy , University of Hertfordshire , Hatfield , Hertfordshire , UK and.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Chilcott
authors.affiliation: a Department of Pharmacy , University of Hertfordshire , Hatfield , Hertfordshire , UK and.
authors.forename: Joanne
authors.initials: J
authors.lastname: Larner
authors.affiliation: a Department of Pharmacy , University of Hertfordshire , Hatfield , Hertfordshire , UK and.
authors.forename: Hazem
authors.initials: H
authors.lastname: Matar
authors.affiliation: a Department of Pharmacy , University of Hertfordshire , Hatfield , Hertfordshire , UK and.
authors.forename: Sneha
authors.initials: S
authors.lastname: Kansagra
authors.affiliation: a Department of Pharmacy , University of Hertfordshire , Hatfield , Hertfordshire , UK and.
authors.forename: Baveetharan
authors.initials: B
authors.lastname: Theivendran
authors.affiliation: a Department of Pharmacy , University of Hertfordshire , Hatfield , Hertfordshire , UK and.
authors.forename: Vanessa Anne
authors.initials: VA
authors.lastname: Viegas
authors.affiliation: b Emergent Biosolutions , Princeton , NJ , USA.
authors.forename: Virginia Streusand
authors.initials: VS
authors.lastname: Goldman
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004890:Erythema / Q000139:chemically induced / Q000517:prevention & control*; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008875:Middle Aged; D009539:Nicotinic Acids / Q000633:toxicity; D020011:Protective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D012867:Skin / Q000187:drug effects*; D063465:Skin Cream / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D009539:Nicotinic Acids; D020011:Protective Agents; C008473:methyl nicotinate
keywords: Clinical study; human volunteer; methyl nicotinate; rubefacient; topical treatment; white petroleum jelly