Investigation on the clinical efficacy and safety of 0.1% tacrolimus ointment (Protopic®) in canine atopic dermatitis: A randomized, double-blinded, placebo-controlled, cross-over study

Veterinary Dermatology

Volumn 15, Issue 5, 2004, Pages 294-303

  Marsella, R ^a   Nicklin, C F ^a   Saglio, S ^a   Lopez, J ^a  

^a University of Florida College of Veterinary Medicine   (United States)

Author keywords

Atopic dermatitis; Dogs; Tacrolimus

Indexed keywords

TSUKUBAENOLIDE;

ANIMAL EXPERIMENT; ARTICLE; ATOPIC DERMATITIS; BLOOD CELL COUNT; BLOOD SAMPLING; CROSSOVER PROCEDURE; DOG; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG FORMULATION; DRUG RESPONSE; DRUG SAFETY; ERYTHEMA; EXPERIMENTAL ANIMAL; FEMALE; MALE; NONHUMAN; PARAMETER; PRURITUS; SYMPTOM;

ADMINISTRATION, CUTANEOUS; ANIMALS; CROSS-OVER STUDIES; DERMATITIS, ATOPIC; DOG DISEASES; DOGS; DOUBLE-BLIND METHOD; FEMALE; IMMUNOSUPPRESSIVE AGENTS; MALE; OINTMENTS; PEDIGREE; SEVERITY OF ILLNESS INDEX; TACROLIMUS; TREATMENT OUTCOME;

ANIMALIA; CANIS FAMILIARIS;

EID: 8744241360     PISSN: 09594493     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1365-3164.2004.00397.x     Document Type: Article

References (42)

1. Lazarous, MC, Kerdel, FA. Topical tacrolimus Protopic. Drugs of Today 2002 38: 7-15.
2. Rustin M. Tacrolimus ointment for the management of atopic dermatitis. Hospital Medicine 2003; 64: 214-17.
3. Gewirtz AT, Sitaraman SV. Tacrolimus Fujisawa. Current Opinion in Investigational Drugs 2002; 3: 1307-11.
4. Schreiber SL, Crabtree GR. The mechanism of action of cyclosporine A and FK-506. Immunology Today 1992; 12: 136-42.
5. Sakuma S, Higashi Y, Sato N et al. Tacrolimus suppressed the production of cytokines involved in atopic dermatitis by direct stimulation of human PBMC system. (Comparison with steroids.) International Immunopharmacology 2001; 1: 1219-26.
6. de Paulis A, Stellato C, Cirillo R et al. Anti-inflammatory effect of FK-506 on human skin mast cells. Journal of Investigative Dermatology 1992; 99: 723-8.
7. Thomson AW, Nalesnik M, Abu-Elmagd K et al. The influence of FK-506 on T lymphocytes, Langerhans' cells, and the expression of cytokine receptors and adhesion molecules in psoriatic skin: a preliminary study. Transplantation Proceedings 1991; 23: 3330-1.
8. Wollenberg A, Sharma S, von Bubnoff D et al. Topical tacrolimus (FK506) leads to profound phenotypic and functional alterations of epidermal antigen-presenting dendritic cells in atopic dermatitis. Journal of Allergy and Clinical Immunology 2001; 107: 519-25.
9. Panhans-Gross A, Novak N, Kraft S et al. Human epidermal Langerhans' cells are targets for the immunosuppressive macrolide tacrolimus (FK506). Journal of Allergy and Clinical Immunology 2001; 107: 345-52.
10. Trautmann A, Akdis M, Schmid-Grendelmeier P et al. Targeting keratinocyte apoptosis in the treatment of atopic dermatitis and allergic contact dermatitis. Journal of Allergy and Clinical Immunology 2001; 108: 839-46.
11. Trautmann A, Akdis M, Klunker S et al. Role of apoptosis in atopic dermatitis. International Archives of Allergy and Immunology 2001; 124: 230-2.
12. Fleischer AB Jr, Ling M, Eichenfield L et al. Tacrolimus ointment for the treatment of atopic dermatitis is not associated with an increase in cutaneous infections. Journal of the American Academy of Dermatology 2002; 47: 562-70.
13. Rico MJ, Lawrence I. Tacrolimus ointment for the treatment of atopic dermatitis: clinical and pharmacologic effects. Allergy and Asthma Proceedings 2002; 23: 191-7.
14. Gupta AK, Adamiak A, Chow M. Tacrolimus. A review of its use for the management of dermatoses. Journal of the European Academy of Dermatology and Venereology 2002; 16: 100-14.
15. Allen BR. Tacrolimus ointment: its place in the therapy of atopic dermatitis. Journal of Allergy and Clinical Immunology 2002; 109: 401-3.
16. Marsella R, Olivry T. Animal models of atopic dermatitis. Clinics in Dermatology 2003; 21: 122-33.
17. Marsella R, Olivry T. The ACVD task force on canine atopic dermatitis: mediators of cutaneous inflammation. Veterinary Immunology and Immunopathology 2001; 81: 205-13.
18. Marsella R, Nicklin CF. Double blinded-placebo controlled, cross-over study to evaluate the efficacy and safety of 0.3% topical tacrolimus in canine atopic dermatitis. Veterinary Dermatology 2002; 13: 203-10.
19. Nakagawa H, Etoh T, Ishibashi Y et al. Tacrolimus ointment for atopic dermatitis. Lancet 1994; 344: 883.
20. Boguniewicz M, Fiedler VC, Raimer S et al. A randomized, vehicle controlled trial of tacrolimus ointment for the treatment of atopic dermatitis in children. Journal of Allergy and Clinical Immunology 1998; 102: 637-44.
21. Takada K, Katayama N, Kiriyama A, Usuda H. Distribution characteristics of immunosuppressants FK506 and cyclosporin A in the blood compartment. Biopharmaceutics and Drug Disposition 1993; 14: 659-71.
22. Venkataramanan R, Warty VS, Zemaitis MA et al. Biopharmaceutical aspects of FK-506. Transplantation Proceedings 1987; 19: 30-5.
23. Olivry T, Rivierre C, Jackson HA et al. Cyclosporine decreases skin lesions and pruritus in dogs with atopic dermatitis: a blinded randomized prednisolone-controlled trial. Veterinary Dermatology 2002; 13: 77-87.
24. Sugiura H, Uehara M, Hoshino N et al. An open study of a lotion formulation to improve tolerance of tacrolimus in facial atopic dermatitis. British Journal of Dermatology 2001; 145: 795-8.
25. Drake L, Prendergast M, Maher R et al. The impact of tacrolimus ointment on health-related quality of life of adult and pediatric patients with atopic dermatitis. Journal of the American Academy of Dermatology 2001; 44: S65-72.
26. Kang S, Lucky AW, Pariser D et al. Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. Journal of the American Academy of Dermatology 2001; 44: S58-64.
27. Kang S, Paller A, Soter N et al. Safe treatment of head/neck AD with tacrolimus ointment. Journal of Dermatological Treatment 2003; 14: 86-94.
28. Reitamo S, Wollenberg A, Schopf E et al. Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. Archives of Dermatology 2000; 136: 999-1006.
29. Soter NA, Fleischer AB Jr, Webster GF et al. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. Journal of the American Academy of Dermatology 2001; 44: S39-46.
30. Hanifin JM, Ling MR, Langley R et al. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part I, efficacy. Journal of the American Academy of Dermatology 2001; 44: S28-38.
31. Olivry T, Steffan J, Fisch RD et al. Randomized controlled trial of the efficacy of cyclosporine in the treatment of atopic dermatitis in dogs. Journal of the American Veterinary Medical Association 2002; 221: 370-7.
32. Deboer DJ, Schafer JH, Salsbury CS et al. Multiple-center study of reduced-concentration triamcinolone topical solution for the treatment of dogs with known or suspected allergic pruritus. American Journal of Veterinary Research 2002; 63: 408-13.
33. Reitamo S, Rustin M, Ruzicka T et al. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis. Journal of Allergy and Clinical Immunology 2002; 109: 547-55.
34. Ellis CN, Drake LA, Prendergast MM et al. Cost-effectiveness analysis of tacrolimus ointment versus high-potency topical corticosteroids in adults with moderate to severe atopic dermatitis. Journal of the American Academy of Dermatology 2003; 48: 553-63.
35. Constance C, Pournaras JL, Saurat JH. Staphylococcal colonization in atopic dermatitis treatment with topical tacrolimus (FK506). Journal of Investigative Dermatology 2001; 116: 480-1.
36. Petzelbauer P, Wolff K. Effects of cyclosporin A on resident and passenger immune cells of normal human skin and UV-induced erythema reactions. British Journal of Dermatology 1992; 127: 560-5.
37. Dupuy P, Bagot M, Michel L et al. Cyclosporin A inhibits the antigen-presenting functions of freshly isolated human Langerhans cells in vitro. Journal of Investigative Dermatology 1991; 96: 408-13.
38. Haftek M, Urabe A, Kanitakis J et al. Cyclosporin A inhibits DNA synthesis by epidermal Langerhans cells. Regional Immunology 1990-91; 3: 236-41.
39. Steffan J, Alexander D, Brovedani F et al. Comparison of cyclosporine A with methylprednisolone for treatment of canine atopic dermatitis: a parallel, blinded, randomized controlled trial. Veterinary Dermatology 2003; 14: 11-22.
40. Monti P, Mercalli A, Leone BE et al. Rapamycin impairs antigen uptake of human dendritic cells. Transplantation 2003; 75: 137-45.
41. Nghiem P, Pearson G, Langley RG. Tacrolimus and pimecrolimus. From clever prokaryotes to inhibiting calcineurin and treating atopic dermatitis. Journal of the American Academy of Dermatology 2002; 46: 228-41.
42. Meurer M, Folster-Holst R, Wozel G et al. Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Dermatology 2002; 205: 271-7.