Irritation and allergy patch test analysis of topical treatments commonly used in wound care: Evaluation on normal and compromised skin

• Published in: Journal of the American Academy of Dermatology 2011-03, Vol.64 (3), p.S16-S22
• Main Authors: Trookman, Nathan S., MD, FAAD, Rizer, Ronald L., PhD, Weber, Teresa, PhD
• Format: Article
• Language: English
• Subjects: Administration, Topical; Adolescent; Adult; Aged; allergic contact dermatitis; Aquaphor Healing Ointment; bacitracin; Bacitracin - therapeutic use; Biafine Topical Emulsion; cumulative irritation; Dermatitis, Allergic Contact - etiology; Dermatology; Drug Combinations; Emulsions - therapeutic use; Female; Gramicidin - therapeutic use; Humans; Lipids - therapeutic use; Male; Middle Aged; Neomycin - therapeutic use; Neosporin; Ointments - therapeutic use; patch testing; Patch Tests; Petrolatum - therapeutic use; Polymyxin B - therapeutic use; Polysporin; Skin Irritancy Tests - methods; Theophylline - therapeutic use
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2010.11.008

Background Topical agents indicated for the treatment of superficial wounds have the potential to cause irritation or allergic contact dermatitis, particularly when applied to an impaired skin barrier. Objective We sought to compare the irritancy potential of 5 topical wound care products commonly used in dermatologic practice on normal and compromised skin. Methods Agents tested included Aquaphor Healing Ointment (AHO) (Beiersdorf Inc, Wilton, CT); bacitracin; Biafine Topical Emulsion (BTE) (OrthoNeutrogena, Los Angeles, CA); Neosporin (Poly/Bac/Neo) (Johnson & Johnson, New Brunswick, NJ); and Polysporin (Poly/Bac) (Johnson & Johnson). Study 1 assessed cumulative irritation using a modified human repeat insult patch test on normal back skin with an induction phase (test materials applied under occlusive patch 9 times at 48- to 72-hour intervals) and a challenge phase (test materials applied to original and naïve sites for 48 hours, 12-24 days postinduction). Irritation was graded for erythema and type IV allergy skin responses. Study 2 assessed the acute irritation potential of agents on tape-stripped (“wounded”) back skin. Test sites were graded for erythema, transepidermal water loss, and skin color (Chroma Meter a∗) (Minolta, Osaka, Japan) at 48 and 72 hours poststripping. Results In study 1, cumulative irritation testing in 108 subjects classified AHO, bacitracin, Poly/Bac/Neo, and Poly/Bac as “mild,” and BTE as “probably mild.” In study 2 at 72 hours, mean clinical grading scores were significantly higher for BTE and Poly/Bac/Neo than AHO. Transepidermal water loss and colorimeter a∗ values were significantly lower for AHO and bacitracin compared with BTE. No allergic contact dermatitis was seen in either study. Conclusions Patch test studies demonstrated that BTE showed the greatest irritancy potential in both normal and compromised skin whereas AHO showed the least.