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 Table of Contents  
Year : 2021  |  Volume : 7  |  Issue : 2  |  Page : 95-96

Amorolfine-induced allergic contact dermatitis

Department of Clinical and Experimental Pharmacology, Calcutta School of Tropical Medicine, Kolkata, West Bengal, India

Date of Submission13-Jul-2020
Date of Decision03-Jun-2021
Date of Acceptance04-Jun-2021
Date of Web Publication14-Dec-2021

Correspondence Address:
Kaustav Saha
Department of Clinical and Experimental Pharmacology, Calcutta School of Tropical Medicine, Kolkata - 700 073, West Bengal.
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijdd.ijdd_43_20

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How to cite this article:
Saha K, Mukherjee S. Amorolfine-induced allergic contact dermatitis. Indian J Drugs Dermatol 2021;7:95-6

How to cite this URL:
Saha K, Mukherjee S. Amorolfine-induced allergic contact dermatitis. Indian J Drugs Dermatol [serial online] 2021 [cited 2022 Aug 8];7:95-6. Available from: https://www.ijdd.in/text.asp?2021/7/2/95/332423


Amorolfine, a new class of antifungal agents, is used for dermatomycoses caused by dermatophytes: Tinea pedis, tinea cruris, tinea inguinalis, tinea corporis, tinea manuum, and pityriasis versicolor. This phenylpropyl morpholine derivative acts by inhibiting ergosterol biosynthesis in the fungal cell membrane. Alterations in membrane sterol content led to changes in membrane permeability and disruption of fungal metabolic processes.[1] It acts on two different enzymes involved in sterol biosynthesis, which results in the depletion of ergosterol. This twofold mechanism of action makes it a potent fungistatic and fungicidal agent. Amorolfine is available as cream and nail lacquer, with treatment duration being much dependent on the fungal species and infection localization. The treatment should be continued until clinical cure and for 3–5 days thereafter.[2] With foot mycoses, up to 6 weeks of therapy may however be needed. Various treatment options are available either as monotherapy, combination therapy, or sequential therapy. However, its use in pregnant women, children, and elderly needs a cautious approach. Safety concerns with this antifungal agent are relatively rare, with few reported reactions involving immune system disorders and skin and subcutaneous tissue disorders. The present report describes a case of allergic contact dermatitis (ACD) after starting empirical therapy with topical amorolfine for a suspected cutaneous dermatomycosis infection.

A 28-year-old normotensive euglycemic male presented with itchy eczematous rash with vesiculation on the dorsal surface of both legs after using amorolfine 0.25% over the last 14 days. On history elucidation, he initially presented with cutaneous dermatomycosis on several areas of limbs and chest. Dermatophyte, dimorphic, dematiaceous, or filamentous fungi infection was suspected, and specimens were taken for bacterial and fungal culture. Fungal cultures were negative; however, given the strong clinical suspicion, topical treatment was initiated with 1% luliconazole ointment twice daily. Along with that tablet terbinafine 250 mg and capsule itraconazole 200 mg were started. Two weeks later, the patient improved but not significantly. He was advised to continue the same medication for the next 2 weeks. On subsequent follow-ups, the severity of infection was much improved, but it left some marks on the skin, which in our opinion was incomplete healing. Therefore, amorolfine cream (Fungicross® 0.25%) was added to his earlier regimen. After 2 weeks, the patient developed ACD presenting as itchy eczematous rash coupled with vesicles on the dorsal areas of both feet [Figure 1]. Patch testing was conducted for amorolfine and other contents of the cream. Testing conferred positive results (+++) for amorolfine suggestive of ACD due to amorolfine. Amorolfine was withdrawn immediately, and the patient was asked to follow-up after 7 days. At follow-up 1 week later, clinical examination revealed reduced and dried-up lesions on the dorsal face of the legs [Figure 2]. After another week, the eczematous lesions completely weaned off [Figure 3]. The dermatomycosis was also improved by that time. Causality and severity assessment of the reaction conferred it to “probable”[3],[4] and “mild,”[5] respectively. The reaction was reported to Pharmacovigilance Programme of India.
Figure 1: Lesions on initial presentation

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Figure 2: Lesions on presentation at day 7

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Figure 3: Lesions on presentation at day 14

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Although ACD secondary to amolorfine nail lacquer is reported,[6] ACD due to cream formulation is not frequently reported in the literature.[7]

Cutaneous complications to antifungal agents are not uncommon. However, such events lead to complications of the ongoing therapy as it prolongs persisting infection status. Prompt drug withdrawal is the only option in such cases.


The authors would like to acknowledge and support the untiring efforts and contribution of Pharmacovigilance Programme of India toward ensuring better patient safety nationwide.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient has given his consent for his images and other clinical information to be reported in the journal. The patient understands that name and initial will not be published and due efforts will be made to conceal identity, but anonymity cannot be guaranteed.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

  References Top

Banerjee M, Ghosh AK, Basak S, Das KD, Gangopadhyay DN. Comparative evaluation of effectivity and safety of topical amorolfine and clotrimazole in the treatment of tinea corporis. Indian J Dermatol 2011;56:657–62.  Back to cited text no. 1
[PUBMED]  [Full text]  
Haria M, Bryson HM. Amorolfine. A review of its pharmacological properties and therapeutic potential in the treatment of onychomycosis and other superficial fungal infections. Drugs 1995;49:103–20.  Back to cited text no. 2
The Use of the WHO-UMC System for Standardised Case Causality Assessment. Available from: http://www.who-umc.org/Graphics/24734.pdf. [Last accessed on 2020 Mar 09].  Back to cited text no. 3
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239–45.  Back to cited text no. 4
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229–32.  Back to cited text no. 5
Fidalgo A, Lobo L. Allergic contact dermatitis due to amorolfine nail lacquer. Dermatitis 2004;15:54.  Back to cited text no. 6
Kaneko K, Aoki N, Hata M, Yajima J, Kawana S, Hattori S. Allergic contact dermatitis from amorolfine cream. Contact Dermatitis 1997;37:307.  Back to cited text no. 7


  [Figure 1], [Figure 2], [Figure 3]


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