Contact dermatitis from an anti-haemorroidal cream containing ruscogenin

ARTICLE

Auteur(s) : Susana Córdoba, Cristina Martínez-Moràn, Almudena Hernàndez-Nuñez, Jesús Borbujo

Dept of Dermatology, Hospital Universitario de Fuenlabrada, Camino del Molino, 2, 28942 Fuenlabrada, Spain

Ruscus aculeatus L. is a member of the Liliaceae family and is native to Mediterranean Europe and Africa. It has been widely used as a laxative and diuretic agent and as a vasoconstrictor in the topical treatment of varices and haemorrhoids. The pharmacological activity of Ruscus aculeatus L. is attributed to steroidal saponins, mainly ruscogenin (figure 1) and neoruscogenin, which have venoconstricting and antiinflammatory effects [1, 2].

A 35-year-old man presented with pruritic erythematous lesions on the perianal area and buttocks 5 days after initiating the local application of Ruscus Llorens^® (Llorens, Barcelona, Spain) cream for haemorrhoids. The lesions became papulo-erythematous, well-defined and spread within a day to the trunk and both legs.

The patient had used other antihaemorrhoidal creams previously with no cutaneous reactions. Therapy with the cream was stopped and the patient was successfully treated with oral corticosteroids.

The antihaemorrhoidal cream contained ruscogenin, cinchocaine hydrochloride (dibucaine), prednisolone, menthol, zinc oxide and other excipients in its composition. The patient was patch tested with GEIDAC (Spanish Group of Investigation of Contact Dermatitis) standard series, local anaesthetics series and Ruscus llorens^® cream as is. Caine mix, tixocortol pivalate, Ruscus llorens^® cream, and cinchocaine patch tests were positive (++) at 48 and 96 hours, and tetracaine (++) and lidocaine (+) at 96 hours.

One month later patch testing with Ruscus llorens^® cream and with separate ingredients of the cream that were provided by the commercial laboratory was performed, showing positive (+++) results for ruscogenin 1% pet, cinchocaine 5% pet and Ruscus llorens^® cream as is at 48 and 96 h. Further tests with corticosteroid series produced positive reactions (+) to hydrocortisone and hydrocortisone acetate at 7 days but negative to prednisolone (contained in Ruscus llorens^® cream). Patch tests with ruscogenin 1% pet were negative in five controls.

Patients with haemorrhoids apply multiple topical drugs and allergic contact dermatitis is frequently observed in these patients. Local anaesthetics are, by far, the most common allergens but other topical medicaments may cause sensitization too [3]. On the basis of structural similarities, local anesthetics are divided into esters and amides. Our patient reacted to cinchocaine and lidocaine which are amides but also to a member of the ester group, tetracaine. Ester local anaesthetics are common causes of contact sensitization and cross-reactivity within the ester group is well known [3, 4]. However, multiple sensitivities to local anesthetics cannot be predicted only on the basis of structural groups. Patients reacting to more than one anaesthetic may react to both groups [4].

Cinchocaine had been considered a rare cause of contact sensitization but some studies have reported that allergy to cinchocaine is most prevalent after benzocaine [4]. The differences reported may be due to variations in the use of cinchocaine in different countries.

Positive patch tests to tixocortol pivalate, hydrocortisone and hydrocortisone acetate suggested type A corticosteroid sensitization in our case. We cannot explain the negative result to the prednisolone patch test. A false negative reaction or previously unknown sensitizations are possible explanations.

Ruscogenin has been considered to be safe and lists no contraindications. Contact dermatitis has been previously reported in two patients topically exposed to ruscogenin (contained in anti-haemorroidal cream [5] and in anti-cellulitis cream [6]). Patch tests in healthy controls have been reported negative and ruscogenin has been considered non irritant on patch testing. Ruscogenin can be contained in numerous topical preparations such as antihaemorroidal creams, cosmetic products for application to the skin, after shave and after depilation products. Although contact dermatitis to ruscogenin is a rare event to date, it is probably underreported. We emphasize the importance of taking it into account.

Acknowledgements

References

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3 Brandao FM, Goosens A, Tosti A. Topical drugs. In: En Frosch PJ, Menné T, Leipottevin JP, eds. Contact Dermatitis. 4th Edition. Springer-Verlag, 2006: 45-68.

4 Warshaw EM, Schram E, Belsito DV, DeLeo VA, Fowler JF, Maibach HI, et al. Patch-test reactions to topical anesthetics: retrospective analysis of cross-sectional data, 2001 to 2004. Dermatitis 2008; 19: 81-5.

5 Landa N, Aguirre A, Goday J, Ratón JA, Díaz-Pérez JL. Allergic contact dermatitis from a vasoconstrictor cream. Contact Derm 1990; 22: 290.

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