The low concentration of propylene glycol (PG) in pimecrolimus cream makes it unlikely that the cream will induce a PG-related irritant or allergic contact dermatitis.
Objective:
To assess reactions to pimecrolimus cream in patients who are allergic to PG.
Methods:
A pilot double-blind within-patient study in 20 patients, with patch testing followed by a repeated open application test (ROAT). Limitations were that patch tests and ROATs were performed on normal skin, which may be less likely to develop an allergic response than would areas of active dermatitis.
Results:
Positive PG patch-test results were confirmed in 16 patients. Patch-test scores were compatible with allergic reactions in only two patients. However, ROAT scores were negative for these two patients. Reactions with pimecrolimus or vehicle during ROAT were identified in three patients, but an allergic reaction was uncertain because none of these patients reacted with both pimecrolimus cream and vehicle. Reactions with pimecrolimus were significantly less frequent (p < .01) and less severe (p = .02) than with PG.
Conclusion:
In patients allergic to PG, pimecrolimus cream showed a very low potential to elicit allergic skin reactions.
Get full access to this article
View all access options for this article.
References
1.
FowlerJF. Contact allergy to propylene glycol in topical corticosteroids. Am J Contact Dermat, 1993; 4:37-8.
2.
GonzaloMA, De ArgilaD, GarciaJM, AlvadarMI. Allergic contact dermatitis to propylene glycol. Allergy, 1999; 54:82-3.
EichenfieldLF, LuckyAW, BoguniewiczM, et al.Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. J Am Acad Dermatol, 2002; 46:495-504.
12.
WahnU, BosJD, GoodfieldM, et al.Efficacy and safety of pimecrolimus cream in the long-term management of atopic dermatitis in children. Pediatrics, 2002; 110:e2.
13.
MeurerM, Folster-HolstR, WozelG, et al.Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Dermatology, 2002; 205:271-7.
14.
KappA, PappK, BinghamA, et al.Long-term management of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid anti-inflammatory drug. J Allergy Clin Immunol, 2002; 110:277-84.
15.
HoVC, GuptaA, KaufmannR, ToddG, et al.Safety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants. J Pediatr, 2003; 142:155-62.
16.
StuetzA, GrassbergerM, MeingassnerJG. Pimecrolimus (Elidel, SDZ ASM 981)—preclinical pharmacologic profile and skin selectivity. Semin Cutan Med Surg, 2001; 20:233-41.
17.
Elidel® (pimecrolimus) cream 1% full prescribing information. Novartis Pharmaceuticals East Hanover, NJ. Rev: July2004.
18.
HannukselaM, SaloH. The repeated open application test (ROAT). Contact Dermatitis, 1986; 14:221-7.
