title: A prospective crossover pilot study to evaluate the use of a topical wound gel in patients with cutaneous toxicity caused by epidermal growth factor receptor inhibitors.
abstract: One of the dose-limiting toxicities of epidermal growth factor receptor inhibitors (EGFRIs) is a papulopustular rash that is often pruritic and painful. Secondary skin infection can occur from scratching to relieve the pruritus. Studies suggest that this rash might be a surrogate marker for efficacy; therefore, effective rash management is needed to allow patients to use EGFRIs without unnecessary dose modifications. In this single-center, prospective, crossover study, we evaluated the use of a topical gel (Regenecare Wound Gel) for relieving the pruritus and pain of EGFRI-induced rash among oncology patients. The secondary end points were patient satisfaction, adverse effects, and EGFRI dose modifications. At the occurrence of grade 2 skin rash, patients started applying the study gel to the right side of their face; after 1 week, they began applying it to both sides of their face for up to an additional 5 weeks. Each week, providers performed a facial evaluation and patients rated their symptoms and satisfaction on questionnaires. Of the 20 patients enrolled, 13 were evaluable. Reduction in itch at the end of week 1 was greater on the right (treated) side in 69% of patients greater on the left (untreated) side in 8%, and the same in 23% (P = 0.01). The pattern was similar for pain, but the differences were not significant. On average, patients rated the gel as being moderately to extremely effective for alleviating symptoms, improving rash appearance, and promoting healing and found it easy to apply. No adverse effects were documented. Four patients (31%) required EGFRI dose modifications because of rash. Taken together, these findings suggest that the topical wound gel is effective in relieving rash-associated itching in patients receiving EGFRIs and is associated with high patient satisfaction.
authors.affiliation: Loma Linda University, School of Pharmacy, Loma Linda, California 92350, USA. sfwong@llu.edu
authors.forename: Siu-Fun
authors.initials: SF
authors.lastname: Wong
authors.forename: Alexander
authors.initials: A
authors.lastname: Lindgren
authors.forename: Madhavi
authors.initials: M
authors.lastname: Mummaneni
authors.forename: Timothy
authors.initials: T
authors.lastname: Byun
authors.forename: Catherine
authors.initials: C
authors.lastname: Vasko
authors.forename: Rachel
authors.initials: R
authors.lastname: Arenos
authors.forename: Edward
authors.initials: E
authors.lastname: Alexson
authors.forename: Kathryn
authors.initials: K
authors.lastname: Osann
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D003875:Drug Eruptions / Q000188:drug therapy* / Q000209:etiology; D066246:ErbB Receptors / Q000037:antagonists & inhibitors* / Q000378:metabolism; D005076:Exanthema / Q000139:chemically induced / Q000188:drug therapy*; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D011537:Pruritus / Q000139:chemically induced / Q000188:drug therapy; D011788:Quality of Life; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D005782:Gels; C512478:EGFR protein, human; D066246:ErbB Receptors