title: Topical corticosteroid has no influence on inflammation or efficacy after ingenol mebutate treatment of grade I to III actinic keratoses (AK): A randomized clinical trial.
abstract: BACKGROUND
  Ingenol mebutate (IngMeb) is approved for treatment of actinic keratoses (AK) and may cause unpredictable local skin responses (LSR).
  
  
  OBJECTIVE
  We sought to investigate whether IngMeb-induced LSR, pain, and pruritus could be alleviated with a topical glucocorticoid and, further, to assess efficacy, cosmetic outcome, and patient satisfaction in patients with severe photodamage.
  
  
  METHODS
  In this blinded, randomized controlled clinical trial, patients with multiple AK and field cancerization of the face or scalp were treated in 2 areas with IngMeb (0.015%) daily for 3 days. After finalized IngMeb treatment, 1 area was randomized to receive topical clobetasol propionate (0.05%) twice daily for 4 days. Assessments included LSR (0-24; days 1, 4, 8, 15, 57), pain (0-10) and pruritus (0-3; days 1-15), AK clearance (days 15, 57), and cosmetic outcome (0-3; day 57).
  
  
  RESULTS
  Clobetasol propionate application had no influence on LSR (P = .939), pain (P = .500), pruritus (P = .312), or AK cure rate (P = .991). Overall, IngMeb cleared 86% of all AK lesions, exerting a therapeutic effect on all AK severity grades; cure rates were 88%, 70%, and 60% for grade I, II, and III AK, respectively. Skin texture improved significantly in remedied areas (2.0 vs 1.0; P < .001); no hypopigmentation, hyperpigmentation, or scarring were observed.
  
  
  CONCLUSIONS
  These results do not provide safety and efficacy beyond 2 months of follow-up.
  
  
  CONCLUSIONS
  Application of clobetasol propionate does not alleviate IngMeb-induced LSR after 3 days of IngMeb treatment.
authors.affiliation: Department of Dermatology, Bispebjerg University Hospital, University of Copenhagen, Copenhagen, Denmark. Electronic address: andres.erlendsson@gmail.com.
authors.forename: Andrés Már
authors.initials: AM
authors.lastname: Erlendsson
authors.affiliation: Department of Dermatology, Bispebjerg University Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Katrine Elisabeth
authors.initials: KE
authors.lastname: Karmisholt
authors.affiliation: Department of Dermatology, Bispebjerg University Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Christina Skovbølling
authors.initials: CS
authors.lastname: Haak
authors.affiliation: Hudklinikken på Jaegersborg Alle, Copenhagen, Denmark.
authors.forename: Ida-Marie
authors.initials: IM
authors.lastname: Stender
authors.affiliation: Department of Dermatology, Bispebjerg University Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Merete
authors.initials: M
authors.lastname: Haedersdal
mesh_terms: D000287:Administration, Topical; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D002990:Clobetasol / Q000627:therapeutic use*; D003718:Denmark; D004224:Diterpenes / Q000009:adverse effects* / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005148:Facial Dermatoses / Q000175:diagnosis / Q000188:drug therapy; D005260:Female; D005500:Follow-Up Studies; D005782:Gels / Q000627:therapeutic use; D006801:Humans; D055623:Keratosis, Actinic / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced / Q000188:drug therapy / Q000503:physiopathology; D011537:Pruritus / Q000139:chemically induced / Q000188:drug therapy / Q000503:physiopathology; D018570:Risk Assessment; D012536:Scalp Dermatoses / Q000175:diagnosis / Q000188:drug therapy; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: C486592:3-ingenyl angelate; D000305:Adrenal Cortex Hormones; D004224:Diterpenes; D005782:Gels; D002990:Clobetasol
keywords: actinic keratoses; actinic keratosis; blinded; clearance; clobetasol; corticosteroid; cosmesis; cosmetic outcome; cure rate; glucocorticoid; hyperkeratotic; inflammation; ingenol mebutate; local skin responses; pain; patient satisfaction; photodamage; pruritus; rejuvenation; skin texture