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

• Published in: Journal of the American Academy of Dermatology 2016-04, Vol.74 (4), p.709-715
• Main Authors: Erlendsson, Andrés Már, MD, PhD, Karmisholt, Katrine Elisabeth, MD, Haak, Christina Skovbølling, MD, PhD, Stender, Ida-Marie, MD, PhD, Haedersdal, Merete, MD, PhD, DMSc
• Format: Article
• Language: English
• Subjects: actinic keratoses; actinic keratosis; Administration, Topical; Adrenal Cortex Hormones - therapeutic use; Aged; Aged, 80 and over; blinded; clearance; clobetasol; Clobetasol - therapeutic use; corticosteroid; cosmesis; cosmetic outcome; cure rate; Denmark; Dermatology; Diterpenes - adverse effects; Diterpenes - therapeutic use; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Facial Dermatoses - diagnosis; Facial Dermatoses - drug therapy; Female; Follow-Up Studies; Gels - therapeutic use; glucocorticoid; Humans; hyperkeratotic; inflammation; ingenol mebutate; Keratosis, Actinic - diagnosis; Keratosis, Actinic - drug therapy; local skin responses; Male; Middle Aged; pain; Pain - chemically induced; Pain - drug therapy; Pain - physiopathology; patient satisfaction; photodamage; pruritus; Pruritus - chemically induced; Pruritus - drug therapy; Pruritus - physiopathology; rejuvenation; Risk Assessment; Scalp Dermatoses - diagnosis; Scalp Dermatoses - drug therapy; Severity of Illness Index; Single-Blind Method; skin texture; Treatment Outcome
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2015.11.034

Background Ingenol mebutate (IngMeb) is approved for treatment of actinic keratoses (AK) and may cause unpredictable local skin responses (LSR). Objectives 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