Protopic has been studied in more than 14,000 patients worldwide1
Protopic is one of the most extensively studied dermatology products ever—with more than 14,000 patients, including 6000 children, involved in clinical studies1. Abstracts of some of the more important studies are available below. If you'd like to read even more, a complete bibliography is also available.
Click on the links below to view an abstract.
Key studies
Fleischer AB Jr, et al. J Am Acad Dermatol. 2002;47:562-570.
Hanifin JM, et al. J Am Acad Dermatol. 2001;44(suppl):S28-S38.
Paller A, et al. Ann Dermatol Venereol. 2002;129:1S247.
Soter NA, et al. J Am Acad Dermatol. 2001;44(suppl):S39-S46.
Key pediatric studies
Paller A, et al. J Am Acad Dermatol. 2001;44(suppl):S47-S57.
Kang S, et al. J Am Acad Dermatol. 2001;44(suppl):S58-S64.
Full Bibliography
Alaiti S, Kang S, Fiedler VC, et al. Tacrolimus (FK506) ointment for atopic dermatitis: a phase I study in adults and children. J Am Acad Dermatol. 1998;38:69-76.
Boguniewicz M, Fiedler VC, Raimer S, Lawrence ID, Leung DYM, Hanifin JM, for the Pediatric Tacrolimus Study Group. A randomized, vehicle-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children. J Allergy Clin Immunol. 1998;102:637-644.
Cheer SM, Plosker GL. Tacrolimus ointment: a review of its therapeutic potential as a topical therapy in atopic dermatitis. Am J Clin Dermatol. 2001;2:389-406.
Fleischer AB Jr. Treatment of atopic dermatitis: role of tacrolimus ointment as a topical noncorticosteroidal therapy. J Allergy Clin Immunol. 1999;104:S126-S130.
Hanifin JM, Ling MR, Langley R, Breneman D, Rafal E, and the Tacrolimus Ointment Study Group. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part I, efficacy. J Am Acad Dermatol. 2001;44(suppl):S28-S38.
Kang S, Lucky AW, Pariser D, Lawrence I, Hanifin JM, and the Tacrolimus Ointment Study Group. Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. J Am Acad Dermatol. 2001;44(suppl):S58-S64.
Koo J, Prose N, Fleischer A, et al. Safety and efficacy of tacrolimus ointment monotherapy in over 7,900 atopic dermatitis patients: results of an open-label study. Proceedings of World Congress of Dermatology. July 2002; Paris, France.
Leung D, Eichenfield L, Fleischer A, et al. Use of tacrolimus ointment in atopic dermatitis patients with limited disease. Proceedings of American Academy of Dermatology. February 2002; New Orleans, La.
Paller A, Eichenfield LF, Leung DYM, Stewart D, Appell M, and the Tacrolimus Ointment Study Group. A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients. J Am Acad Dermatol. 2001;44(suppl):S47-S57.
Reitamo S, Rissanen J, Remitz A, et al. Tacrolimus ointment does not affect collagen synthesis: results of a single-center randomized trial. J Invest Dermatol. 1998;111:396-398.
Ruzicka T, Bieber T, Schopf E, et al, for the European Tacrolimus Ointment Study Group. A short-term trial of tacrolimus ointment for atopic dermatitis. N Engl J Med. 1997;337:816-821.
Schreiber SL, Crabtree GR. The mechanism of action of cyclosporin A and FK506. Immunol Today. 1992;13:136-142.
Soter NA, Fleischer AB Jr, Webster GF, Monroe E, Lawrence I, and the Tacrolimus Ointment Study Group. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. J Am Acad Dermatol. 2001;44(suppl):S39-S46
References
1. Data on file. Fujisawa Healthcare, Inc., Deerfield, Ill.
Important Information
For short-term and intermittent long-term therapy in patients with moderate to severe atopic dermatitis who should avoid the potential risks of conventional therapies or are not adequately responsive to conventional therapies. Both 0.03% and 0.1% ointment can be used for adults. In children aged 2 to 15 years, only Protopic 0.03% is indicated.
The most common adverse events associated with the use of Protopic Ointment included the sensation of skin burning, pruritus, flu-like symptoms, and headache, and it is contraindicated in patients who are hypersensitive to tacrolimus or any of the other ingredients of Protopic.
Protopic Ointment should not be used with occlusive dressings.
Skin infections should be cleared prior to application, and there may be an increased risk of certain skin infections. Patients should minimize or avoid natural or artificial sunlight exposure