title: Phase I study of a topical skin protectant against chemical warfare agents.
abstract: Vesicants and some nerve agents penetrate exposed skin, mainly through the sensitive integration areas of the personal protective equipment. Therefore, improving dermal barrier with a topical agent should reduce the threat of exposure. A topical skin protectant lotion (IB1) was developed to improve protection against chemical warfare agents. Preclinical studies in several animal models have proven the protective efficacy of IB1. Here we present the results of a randomized placebo-controlled, double-blind phase I clinical study, performed with 34 healthy volunteers. The study tested the safety of repeated applications, including ruling out transdermal permeation of magnesium, which may lead to a dangerous blood magnesium level, since the lotion contains magnesium sulfate. Other objectives included detection of dermatological adverse effects, assessment of application convenience, and effect on daily activities. Importantly, no serious adverse effects were recorded and the lotion did not interfere with daily tasks. There were no significant differences in magnesium levels between the placebo and the study groups in any of the applications. No toxic levels of magnesium were found in either group. We conclude that IB1 is probably safe, easily self-applied, and does not cause any significant inconvenience. Therefore, IB1 can be considered as an adjunctive chemical, biological, and radio-nuclear (CBRN) protective aid to field soldiers.
authors.affiliation: CBRN Medicine Branch, Medical Corps, Israel Defense Forces, Tel Hashomer, Israel.
authors.forename: Arik
authors.initials: A
authors.lastname: Eisenkraft
authors.forename: Amir
authors.initials: A
authors.lastname: Krivoy
authors.forename: Aviv
authors.initials: A
authors.lastname: Vidan
authors.forename: Eyal
authors.initials: E
authors.lastname: Robenshtok
authors.forename: Ariel
authors.initials: A
authors.lastname: Hourvitz
authors.forename: Tsvika
authors.initials: T
authors.lastname: Dushnitsky
authors.forename: Gal
authors.initials: G
authors.lastname: Markel
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D002619:Chemical Warfare Agents; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008274:Magnesium / Q000097:blood; D008278:Magnesium Sulfate / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D008889:Military Personnel; D010919:Placebos; D011041:Poisoning / Q000517:prevention & control; D020011:Protective Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D055815:Young Adult
chemical_list: D002619:Chemical Warfare Agents; D010919:Placebos; D020011:Protective Agents; D008278:Magnesium Sulfate; D008274:Magnesium