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

J Am Acad Dermatol. 2011 Mar;64(3 Suppl):S16-22. doi: 10.1016/j.jaad.2010.11.008. Epub 2011 Jan 17.

Abstract

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.

MeSH terms

  • Administration, Topical
  • Adolescent
  • Adult
  • Aged
  • Bacitracin / therapeutic use*
  • Dermatitis, Allergic Contact / etiology*
  • Drug Combinations
  • Emulsions / therapeutic use*
  • Female
  • Gramicidin / therapeutic use*
  • Humans
  • Lipids / therapeutic use*
  • Male
  • Middle Aged
  • Neomycin / therapeutic use*
  • Ointments / therapeutic use*
  • Patch Tests
  • Petrolatum / therapeutic use*
  • Polymyxin B / therapeutic use*
  • Skin Irritancy Tests / methods*
  • Theophylline / therapeutic use*

Substances

  • Biafine
  • Drug Combinations
  • Emulsions
  • Lipids
  • Ointments
  • polysporin ointment
  • Bacitracin
  • Gramicidin
  • Petrolatum
  • bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
  • Theophylline
  • Neomycin
  • Polymyxin B