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Vol. 64, No. 4, 2007
Issue release date: November 2007
Gynecol Obstet Invest 2007;64:180–186

Pimecrolimus Cream 1% for Treatment of Vulvar Lichen Simplex Chronicus: An Open-Label, Preliminary Trial

Goldstein A.T. · Parneix-Spake A. · McCormick C.L. · Burrows L.J.
aDivision of Gynecologic Specialties, Department of Gynecology and Obstetrics, Johns Hopkins Medicine, Baltimore, Md., and bNovartis Pharmaceuticals Corp., East Hanover, N.J., USA

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Background: To evaluate efficacy and safety of pimecrolimus cream 1% twice daily for treatment of vulvar lichen simplex chronicus (LSC). Methods: Patients in this 12-week, open-label study had biopsy-proven vulvar LSC. Inclusion criteria were patient-reported Visual Analog Scale for Pruritus Relief ≧3 (VAS-PR, 0 cm = no itching to 10 cm = severe itching) and Investigator’s Global Assessment ≧2 (IGA, 0 = no disease to 3 = severe disease). Safety was evaluated by adverse event reports and pimecrolimus blood level measurements. Results: Twelve women aged 25–53 years were enrolled. The median pruritus score (VAS-PR) decreased from 6 (min. 4.9, max. 9.0) at baseline to 0 cm at week 4 (max. 4.2), week 8 (max. 3.1) and week 12 (max. 2.1). Seven patients reported complete resolution of pruritus by week 4. Median IGA decreased from 2.5 (min. 2, max. 3) at baseline to 0 (min. 0, max. 2) at week 12. Erythema, excoriation, and lichenification improved for all patients. Pimecrolimus blood concentration for all samples was below the limit of quantification, 0.3 ng/ml. No adverse events were reported. Conclusions: In this exploratory study, signs and symptoms of vulvar LSC improved for all women and pimecrolimus cream showed a favorable safety profile. Larger prospective studies are needed to further evaluate pimecrolimus for treatment of vulvar LSC.

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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  1. Lynch PJ: Lichen simplex chronicus (atopic/neurodermatitis) of the anogenital region. Dermatol Ther 2004;17:8–19.
  2. Edward J, Wilkinson IKS: Atlas of Vulvar Disease. Baltimore, Williams & Wilkins, 1995.
  3. Foster DC: Vulvar disease. Obstet Gynecol 2002;100:145–163.
  4. Pierard GE, Pierard-Franchimont C, Ben Mosbah T, Arrese Estrada J: Adverse effects of topical corticosteroids. Acta Derm Venereol Suppl (Stockh) 1989;151:26–30, 47–52.
  5. Lubach D, Rath J, Kietzmann M: Steroid-induced dermal thinning: discontinuous application of clobetasol-17-propionate ointment. Dermatology 1992;185:44–48.
  6. Cherian MP, Abduljabbar M: Cushing’s syndrome and adrenal suppression from percutaneous absorption of clobetasol propionate in infants. Saudi Med J 2001;22:1139–1141.
  7. Hugues J, Rustin M: Corticosteroids. Clin Dermatol 1997;15:715–721.
  8. Furue M, Terao H, Rikihisa W, Urabe K, Kinukawa N, Nose Y, et al: Clinical dose and adverse effects of topical steroids in daily management of atopic dermatitis. Br J Dermatol 2003;148:128–133.
  9. Stuetz A, Grassberger M, Meingassner J: Pimecrolimus (Elidel®, SDZ ASM 981): preclinical pharmacologic profile and skin selectivity. Semin Cutan Med Surg 2001;20:233–241.
  10. Hultsch T, Muller KD, Meingassner JG, Grassberger M, Schopf RE, Knop J: Ascomycin macrolactam derivative SDZ ASM 981 inhibits the release of granule-associated mediators and of newly synthesized cytokines in RBL 2H3 mast cells in an immunophilin-dependent manner. Arch Dermatol Res 1998;290:501–507.
  11. Zuberbier T, Chong SU, Grunow K, Guhl S, Walker P, Grassberger M: The ascomycin macrolactam pimecrolimus (Elidel®, SDZ ASM 981) is a potent inhibitor of mediator release from human dermal mast cells and peripheral blood basophils. J Allergy Clin Immunol 2001;108:275–280.
  12. Eichenfield LF, Lucky AW, Boguniewicz M, Langley RG, Cherill R, Marshall K, 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.
  13. Warshaw E, Wohlhuter J, Drake D, Zeller S, Wenner R, Bowers S, et al: Randomized, double-blind, vehicle-controlled efficacy trial of pimecrolimus cream 1% for the treatment of moderate to severe facial seborrheic dermatitis. J Invest Dermatol 2005;125:A3.

    External Resources

  14. Gribetz C, Ling M, Lebwohl M, Pariser D, Draelos Z, Gottlieb AB, et al: Pimecrolimus cream 1% in the treatment of intertriginous psoriasis: a double-blind, randomized study. J Am Acad Dermatol 2004;51:731–738.
  15. Drake LA, Millikan LE: The antipruritic effect of 5% doxepin cream in patients with eczematous dermatitis. Doxepin Study Group. Arch Dermatol 1995;131:1403–1408.
  16. Kaufmann R, Fölster-Holst R, Hoger P, Thaci D, Loffler H, Staab D, et al: Onset of action of pimecrolimus cream 1% in the treatment of atopic eczema in infants. J Allergy Clin Immunol 2004;114:1183–1188.
  17. Queille-Roussel C, Paul C, Duteil L, Lefebvre MC, Rapatz G, Zagula M, et al: The new topical ascomycin derivative SDZ ASM 981 does not induce skin atrophy when applied to normal skin for 4 weeks: a randomized, double-blind controlled study. Br J Dermatol 2001;144:507–513.
  18. Lonsdale-Eccles AA, Velangi S: ‘Topical pimecrolimus in the treatment of genital lichen planus: a prospective case series.’ Br J Dermatol 2005;153:390–394.
  19. Goldstein AT, Marinoff SC, Christopher K: Pimecrolimus for the treatment of vulvar lichen sclerosus in a premenarchal girl. J Pediatr Adolesc Gynecol 2004;17:35–37.
  20. Goldstein AT, Marinoff SC, Christopher K: Pimecrolimus for the treatment of vulvar lichen sclerosus: a report of 4 cases. J Reprod Med 2004;49:778–780.

    External Resources

  21. Wahn U, Bos JD, Goodfield M, Caputo R, Papp K, Manjra A, et al: Efficacy and safety of pimecrolimus cream in the long-term management of atopic dermatitis in children. Pediatrics 2002;110:e2.
  22. Meurer M, Fartasch M, Albrecht G, Vogt T, Worm M, Ruzicka T, et al: Long-term efficacy and safety of pimecrolimus cream 1% in adults with moderate atopic dermatitis. Dermatology 2004;208:365–372.
  23. Luger TA, Lahfa M, Folster-Holst R, Gulliver WP, Allen R, Molloy S, et al: Long-term safety and tolerability of pimecrolimus cream 1% and topical corticosteroids in adults with moderate to severe atopic dermatitis. J Dermatolog Treat 2004;15:169–178.
  24. Fonacier L, Spergel J, Charlesworth EN, Weldon D, Beltrani V, Bernhisel-Broadbent J, et al: Report of the Topical Calcineurin Inhibitor Task Force of the American College of Allergy, Asthma and Immunology and the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol 2005;115:1249–1253.

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