Allergens in Common Brands of Clobetasol
May 2023 | Volume 22 | Issue 5 | 491 | Copyright © May 2023
Published online April 28, 2023
Leena T. Ramani BSa, Wasim Haidari BS BAa, Shalanda Hall BSN DPb, Sima Amin BSa, Sarah S. Chisolm MDc, Steven R. Feldman MD PhDa,d,e
aCenter for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC
bDepartment of Orthopaedic Surgery, Wake Forest Baptist Medical Center, Winston-Salem, NC
cDepartment of Dermatology, Emory University School of Medicine, Atlanta, GA
dDepartment of Pathology, Wake Forest School of Medicine, Winston-Salem, NC
eDepartment of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC
Abstract
Background: Allergic contact dermatitis (ACD) may occur secondary to topical corticosteroids. This may be due to topical corticosteroids containing potential allergens in their vehicles. Variation of allergenic ingredients among various brands of a product has not been well characterized.
Objective: This study aimed to assess the frequency of allergenic ingredients in various brands and manufacturers of clobetasol propionate.
Methods: Common brands of clobetasol propionate were identified online on GoodRx website. Then, ingredient lists for these products were obtained from the US Food & Drug Administration’s Online Label Repository via a proprietary name search. A systematic literature review was performed using the ingredient name on Medline (PubMed) database to find reports of ACD confirmed by patch testing.
Conclusions: Forty-nine different ingredients were identified among all 18 products included, with an average of 8.4 ingredients per product; 19 of these ingredients have allergenic potential, while one has protective effects. Two branded foam formulations contained the greatest number of potential allergens (5), while a shampoo formulation contained no potential allergens. Knowing which allergens are present in different products may be helpful when treating a patient with an allergy or suspected allergy to one of these ingredients.
J Drugs Dermatol. 2023;22(5): doi:10.36849/JDD.4651
Ramani LT, Haidari W, Hall S, et al. Allergens in common brands of clobetasol. J Drugs Dermatol. 2023;22(5):491-495. doi:10.36849/JDD.4651
INTRODUCTION
Topical corticosteroids are one of the most commonly prescribed medications by dermatologists.1 Allergic contact dermatitis (ACD) to topical corticosteroids has been widely recognized since the late 1980s.2 Allergy to corticosteroids often presents as irritation, worsening of dermatitis, or ineffectiveness of treatment with topical corticosteroids.2 When patch testing for suspected allergy to corticosteroids, a corticosteroid series should be used which consists of select corticosteroid chemicals in a vehicle like alcohol or petrolatum.3 Interpreting the results of corticosteroid patch testing is difficult because the anti-inflammatory effect of topical corticosteroids can cause false-negative results at early readings.3,4 Thus reactions such as macular erythema and edge effects often necessitate a second reading, at days 7 to 10, once the initial anti-inflammatory effect has decreased.4-6 A positive patch test for commercial corticosteroids can be misleading as it may indicate an allergy to preservatives or vehicles used in its preparation.2,7 A majority of topical corticosteroids contain at least one potential allergen in their vehicle.7
Previous studies have compared the prevalence of allergenic ingredients in the corticosteroid class between generic and branded products generally.7 More generic products were free of allergens than branded products.7 What is not well characterized is whether the presence of allergenic ingredients differs among specific brands. This study aimed to assess the frequency of allergenic ingredients in various brands of clobetasol propionate.
MATERIALS AND METHODS
Common brands of clobetasol propionate were identified online on GoodRx website. Ingredient lists for Clobex®, Impoyz®, Clodan® kit, OLUX®, OLUX-E®, Temovate®, and Temovate E® products were collected from the U.S. Food & Drug Administration’s Online Label Repository via a proprietary name search (Table 1). The brands Clobevate®, Cormax®, Cormax® scalp, Embeline®, Embeline® E, and Embeline® scalp were not found in the repository and therefore excluded from this review. A systematic literature review was performed using