title: Tolerability of Crisaborole Ointment for Application on Sensitive Skin Areas: A Randomized, Double-Blind, Vehicle-Controlled Study in Healthy Volunteers.
abstract: BACKGROUND
  Inflammatory skin diseases such as atopic dermatitis (AD) and psoriasis often present in sensitive and thin-skinned areas that are at higher risk for topical treatment-related skin irritation (e.g., burning, stinging).
  
  
  OBJECTIVE
  Our objective was to address the need for topical treatments that can be safely applied to these areas. We assessed the local tolerability of crisaborole topical ointment when applied to sensitive and thin-skinned areas of healthy volunteers.
  
  
  METHODS
  In this phase I, randomized, double-blind, vehicle-controlled, single-center study, 32 subjects were randomized 3:1 to twice-daily application of crisaborole topical ointment, 2 %, (n = 24) or vehicle ointment (n = 8) for 21 days to 13 anatomic skin areas, including the face/hairline, genitals, extensor, and intertriginous areas. The primary endpoint was assessment of the frequency and severity of local tolerability symptoms (burning/stinging, erythema, and pruritus) using the Local Tolerability Scale.
  
  
  RESULTS
  Overall, 98.8 % of all tolerability assessments had a grade of 0 (no signs/symptoms of irritation) and 0.1 % had a grade >1 (mild); no differences were observed in the frequency of local tolerability scores between treatment groups. The total frequency of local tolerability assessments graded >0 (none) was lower across all application sites with crisaborole ointment (0.0-2.2 %) than with vehicle ointment (2.4-7.1 %). Local tolerability did not change over time, and was comparable between sensitive and nonsensitive skin areas.
  
  
  CONCLUSIONS
  Crisaborole ointment application to sensitive skin areas was well tolerated in healthy volunteers, supporting its potential role as a topical treatment alternative for patients with AD or psoriasis.
authors.affiliation: Anacor Pharmaceuticals, Inc., 1020 E Meadow Cir, Palo Alto, CA, 94303, USA. lzane@anacor.com.
authors.forename: Lee T
authors.initials: LT
authors.lastname: Zane
authors.affiliation: Anacor Pharmaceuticals, Inc., 1020 E Meadow Cir, Palo Alto, CA, 94303, USA.
authors.forename: Matilda H
authors.initials: MH
authors.lastname: Hughes
authors.affiliation: Department of Clinical Pharmacology, The Royal Adelaide Hospital, Adelaide, SA, Australia.
authors.forename: Sepehr
authors.initials: S
authors.lastname: Shakib
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D001896:Boron Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000008:administration & dosage / Q000009:adverse effects*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D012867:Skin / Q000187:drug effects* / Q000378:metabolism; D055815:Young Adult
chemical_list: D001896:Boron Compounds; D019086:Bridged Bicyclo Compounds, Heterocyclic; D003879:Dermatologic Agents; D009824:Ointments; C543085:crisaborole