The Low Prevalence of Allergic Contact Dermatitis Using a Petrolatum Ointment Containing Lanolin Alcohol

October 2019 | Volume 18 | Issue 10 | Original Article | 1002 | Copyright © October 2019

Zoe Diana Draelos MD,ª Leon H. Kircik MD,b Darrell Rigel MDc

ªDermatology Consulting Services, PLLC, High Point, NC

bIcahn School of Medicine at Mount Sinai, NY; Indiana Medical Center, Indianapolis, IN 

cNew York University Medical Center, New York, NY

Abstract
Lanolin alcohol is a high cholesterol containing naturally derived material used as a skin protectant in wound healing petrolatum-based ointments. It is a highly purified fraction of lanolin wool wax that has been identified as a possible cause of allergic contact dermatitis. This 3-center study enrolled 499 subjects who underwent a variety of in-office surgical procedures followed by application of a wound healing ointment containing lanolin alcohol without antibiotics. No allergic contact dermatitis was identified in the 499 subjects who completed the study. The lack of allergic contact dermatitis observed may be due to the proprietary highly purified lanolin alcohol utilized in the study formulation. This is not the lanolin alcohol preparation found on the standard dermatology patch test tray. Not all lanolin alcohols are equal. This is an important consideration when examining the reported incidence of allergic contact dermatitis to lanolin alcohol and the absence of allergic contact dermatitis demonstrated in this research.

J Drugs Dermatol. 2019;18(10):1002-1004.

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INTRODUCTION

Lanolin alcohol (LA) is an ingredient used in skin protectant ointments for wound healing for its high concentration of cholesterol, a key component of the intercellular lipids.1,2 Purification and fractionation of lanolin (wool wax) yields a subfraction of lanolin alcohol, an ingredient used for over 100 years in skin care products; however many different purities of lanolin alcohol are present in the marketplace.1,2,3 Lanolin alcohol has been identified as an allergen causing allergic contact dermatitis, and for many years was patch tested in concentrations of 30% in petrolatum. In 2011, the concentration of lanolin alcohol, in the standard dermatology patch test series (Amerchol L101 supplied by the manufacturer as 10% in mineral oil) was increased from 30% (final 3% LA) to 50% (final 5% LA).4 In recent publications, this concentration increase has corresponded to higher reported LA allergy rates among those patch tested in clinics due to suspicion of allergy, from about 1.8%-2.5% to 4.6%-5.7%.4,5,6,7 Two manuscripts have cited an increase in the incidence of LA allergy; however they compared allergy rates from 30% LA patch data to more recent 50% data.4,8

A lanolin alcohol containing wound healing ointment is commonly used after various in-office surgical and biopsy procedures, and as post-laser treatment.9,10,11 The incidence of allergic contact dermatitis to LA is unknown in this patient population. This research was undertaken to evaluate the tolerability and safety of an OTC lanolin alcohol-containing skin protectant (Aquaphor Healing Ointment (AHO), Beiersdorf Inc. USA) used for post-surgical skin care.

METHODS

This was a 3 center, open label study of subjects undergoing a variety of in-office surgical procedures. 499 adult male or female subjects age 18-75 years presenting with a lesion that required surgical removal were enrolled in 2 cohorts. Following the completion of informed consent (Allendale IRB, Old Lyme, CT), subjects were evaluated for their ability to meet all of the inclusion criteria and none of the exclusion criteria. Subjects with a lesion on the face, neck, trunk, arms, or legs that required surgical removal accessible to proper wound care and application of the study product were enrolled. Pregnant or breastfeeding females were not enrolled. Subjects with active skin disease, hepatitis, immune deficiency/HIV, autoimmune disease, peripheral vascular impairment, dysfunctional blood clotting, uncontrolled metabolic disease (diabetes, hypertension, hyperthyroidism, or hypothyroidism) as determined by the health questionnaire were not enrolled. Subjects with poor healing, such as keloid formation, were also not enrolled. Subjects had to posses no known allergy or sensitivity to petrolatum, lidocaine, latex, lanolin or lanolin alcohol, or any component of the study wound healing product. No subjects were excluded from the study based on these allergies.

Subjects who had not used creams, ointments, or topical medications in the test area 24 hours prior to the start of the study underwent a surgical procedure appropriate for secondary intention healing. No sutured wounds were allowed. The patients were given post-surgical written and oral at home wound care