BETAMETHASONE DIPROPIONATE POLYACRYLIC FILM‐EORMING LOTION IN THE TREATMENT OF HAND DERMATITIS
Authors: GUPTA ADITYA K. , SHEAR NEIL H. , LESTER ROBERT S. , BAXTER MARY LOU , SAUDER DANIEL N. 
Published: May 2007

The treatment of hand dermatitis is often limited by patients' continued exposure to triggering factors.1 The use of a corticosteroid in a polyacrylic film‐forming vehicle, which forms a relatively impermeable film when applied to the skin, may offer an advantage over traditional steroid lotions by affording protection against irritants while allowing patients to perform routine activities using bare hands. Fifty‐eight (58) men and women ages 18–70 years participated in a 7‐day, double‐blind, randomized, positive controlled study to compare the effectiveness of these two vehicles in the treatment of eczematous hand dermatitis.

Each patient provided written, informed consent before entering the study, which had been approved by the Institution Review Board at the Sunnybrook Health Science Centre, University of Toronto. All patients had a diagnosis of corticosteroid‐responsive dermatitis limited to the hands but were otherwise in good health. Patients were excluded if they had medically significant cutaneous conditions other than eczema of the hands, clinically infected hand dermatitis, or known sensitivity to betamethasone dipropionate or to any vehicle constituents of the products being studied. Therapies that might influence the results were restricted throughout the study and were withdrawn before entering the study as follows: topical corticosteroids, 14 days; systemic corticosteroids, 12 weeks; other topical treatments, 7 days; systemic antimicrobials, all other investigational drugs, radiation therapy (e.g., artificial ultraviolet and tanning devices), 30 days; systemic or topical antihistamlnes, 14 days; and topical anesthetics and topical or systemic analgesics, 48 hours.

Patients were randomly assigned to two groups with one group receiving a film‐forming lotion (FFL) (betametha‐sone dipropionate, 0.05% in a polyacrylic vehicle containing acrylates copolymer, butyl acetate, dibutyl phthalate, isopropyl alcohol, and polyvinyl butyryl). The other group applied a traditional lotion (TL) (betamethasone dipropionate. 0.05% in isopropyl alcohol and purified water slightly thickened with carbomer 934 to resemble the consistency of the other product).2 Bottles were dispensed in their marketed containers with identically appearing overlabels and the contents were not known to the patients or the investigator who assessed the results. Only the study coordinator was aware of the contents of the bottles.

Patients applied a thin layer of the assigned medication with a brush to all affected areas of the hands identified by the study investigator every morning and evening, approximately 10–12 hours apart. Covering the hands with bandages, dressings, or gloves was not allowed, but usual handwashing was permitted. Patients returned for reevaluation on days 2, 4, and 7 of the study.

At each visit the investigator evaluated the severity of hand dermatitis by grading the degree of pruritus, scaling, erythema, induration, and overall severity according to the following scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Pretherapy readings were obtained on day 1 with subsequent readings on days 2, 4, and 7. A physician's global evaluation (PGE) for eczema relief was also performed at each visit in which change from baseline was scored as follows: +3 = cleared, +2 = much improved, +1 = improved, 0 = same, −1 = worse, −2 = much worse. The numerical ratings were averaged for both hands. Cochran‐Mantel‐Haenszel (CMH) methodology with ridit3 assigned scores was used to compare averaged ratings at baseline for the severity of eczema, changes from baseline in eczema severity, and PGE at each subsequent visit.