Topical pimecrolimus for eczema

Cochrane Database of Systematic Reviews

Volumn , Issue 4, 2007, Pages

  Ashcroft, Darren M ^a   Chen, L C ^b   Garside, R ^b   Stein, K ^b   Williams, H C ^b  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b NONE

Author keywords

Administration, topical; Adolescent; Adrenal cortex hormones administration dosage ; Dermatologic agents *administration dosage ; Eczema *drug therapy ; Immunosuppressive agents *administration dosage

Indexed keywords

BETAMETHASONE VALERATE; CALCINEURIN INHIBITOR; CETIRIZINE; CLOBETASONE BUTYRATE; CORTICOSTEROID; DIFLUPREDNATE; EMOLLIENT AGENT; FLUTICASONE PROPIONATE; HYDROCORTISONE BUTYRATE; HYDROCORTISONE VALERATE; MOMETASONE FUROATE; PIMECROLIMUS; PLACEBO; PREDNICARBATE; PREDNIVAL ACETATE; STEROID; TACROLIMUS; TRIAMCINOLONE ACETONIDE;

ADVERSE OUTCOME; BACTERIAL SKIN DISEASE; CANCER RISK; CHILD CARE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; CREAM; DISEASE COURSE; DISEASE EXACERBATION; DISEASE SEVERITY; DOSAGE SCHEDULE COMPARISON; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECZEMA; FOLLOW UP; HUMAN; LYMPHOMA; PATHOGENESIS; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; REVIEW; SCORING SYSTEM; SKIN BURNING SENSATION; SKIN INFECTION; SKIN INJURY; SKIN THINNING; TREATMENT OUTCOME; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VIRAL SKIN DISEASE;

EID: 44949187640     PISSN: 1469493X     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD005500.pub2     Document Type: Review

References (100)

1. ASM981C2315 2005 {unpublished data only} Novartis (protocol ASM981C2315). A 26-week, randomized, multicenter, parallel-group, double-blind, vehicle-controlled study to evaluate the incidence of atopic dermatitis flares when pimecrolimus cream 1% is used at the first signs and/or symptoms of atopic dermatitis and its safety and tolerability in children and adolescents 2-17 years of age. www.novartisclinicaltrials.com/clinicaltrialrepository/public/ login.jsp?target=%2Fclinicaltrialrepository%2Fpublic%2Fmain.jsp (accessed 1st August 2006) 2005.
2. ASM981C2316 2005 {unpublished data only} Novartis (protocol ASM981C2316). A 26-week, randomized, multicenter, parallel-group, double-blind, vehicle-controlled study to evaluate the incidence of atopic dermatitis flares when pimecrolimus cream 1% is used at the first signs and/or symptoms of atopic dermatitis and its safety and tolerability in adults 18 years of age and older. www.novartisclinicaltrials.com/clinicaltrialrepository/public/login.jsp?target= %2Fclinicaltrialrepository%2Fpublic%2Fmain.jsp (accessed 1st August 2006) 2005.
3. ASM981C2402 2005 {unpublished data only} Novartis (protocol ASM981C2402). An exploratory, randomized, double-blind, vehicle-controlled, multicenter, parallel dose study investigating the use of pimecrolimus cream 1% in mild to moderate atopic dermatitis patients who demonstrate a clinical insensitivity to topical glucocorticoids. www.novartisclinicaltrials.com/ clinicaltrialrepository/public/login.jsp?target= %2Fclinicaltrialrepository%2Fpublic%2Fmain.jsp (accessed 1st August 2006) 2005.
4. ASM981CDE10 2005 {unpublished data only} Novartis (protocol ASM981CDE10). A 24-week, randomized, multicenter, parallel-group, double-blind, vehicle-controlled study on pimecrolimus cream 1% assessing the steroid-sparing effect in the long term management of pediatric patients with severe atopic dermatitis. www.novartisclinicaltrials.com/clinicaltrialrepository/public/login. jsp?target=%2Fclinicaltrialrepository%2Fpublic%2Fmain.jsp (accessed 1st August 2006) 2005.
5. Barba 2003 {published data only} Barba JF, Beirana A, Cohen V, Dominguez L, Duran C, Leon G, et al.Pimecrolimus cream 1% is effective, well tolerated and safe in infants and children with atopic eczema of the face. Journal of the European Academy of Dermatology and Venereology. 2003; Vol. 17, issue Suppl 3:P2.35.
6. CASM981C1301 2005 {unpublished data only} Novartis CASM981C1301 Norvatis (protocol CASM981C1301) Norvatis CASM981C1301. Confirmatory study in pediatric patients with atopic dermatitis-multicenter, randomized, double-blind, parallel-group, vehicle-controlled study with a 26-weeks treatment phase to determine the efficacy, safety of pimecrolimus cream for long-term treatment of pediatric patients with atopic dermatitis. www.novartisclinicaltrials.com/clinicaltrialrepository/public/login.jsp?target= %2Fclinicaltrialrepository%2Fpublic%2Fmain.jsp (accessed 1st August 2006) 2005.
7. CASM981C1303 2005 {unpublished data only} Novartis (protocol CASM981C1303). Confirmatory study in adult patients with atopic dermatitis- multicenter, randomized, double-blind, parallel-group, vehicle-controlled study with a 26-week treatment phase to determine the efficacy, safety of pimecrolimus cream for long-term treatment of adult patients with atopic dermatitis. www.novartisclinicaltrials.com/clinicaltrialrepository/ public/login.jsp?target=%2Fclinicaltr (accessed 1st August 2006) 2005.
8. CASM981C2314 2006 {unpublished data only} Novartis (protocol CASM981C2314). A 22-week randomized, multicenter, parallel-group, double-blind study to compare a pimecrolimus cream 1% twice daily (BID) maintenance dosing regimen to a once daily (OD) maintenance dosing regimen in the management of atopic dermatitis in pediatric subjects. www. novartisclinicaltrials.com/clinicaltrialrepository/public/login.jsp?target= %2Fclinicaltr (accessed 31th October 2006) 2006.
9. CASM981C2322 2005 {unpublished data only} Novartis (protocol CASM981C2322). A 4-week, randomized, multicenter, double-blind, vehicle-controlled, parallel-group clinical trial to evaluate the efficacy and safety of pimecrolimus cream 1% in the short-term treatment of patients with mild to moderate Atopic Dermatitis (Eczema). www.novartisclinicaltrials.com/ clinicaltrialrepository/public/login.jsp?target=%2Fclinicaltr (accessed 1st August 2006) 2005.
10. CASM981C2436 2006 {unpublished data only} Novartis (protocol CASM981C2436). A multicenter, 5-week, randomized, double-blind, placebo controlled, parallel group study exploring the effects of pimecrolimus cream 1% (twice daily application) vs. placebo control (twice daily application) on the molecular and cellular profile of adult male patients with atopic dermatitis. www.novartisclinicaltrials.com/clinicaltrialrepository/public/login. jsp?target=%2Fclinicaltr (accessed 1st August 2006) 2006.
11. CASM981C2442 2006 {published data only} Novartis (protocol CASM981C2442). A 12 week multicenter study consisting of a 6 week double blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the safety and efficacy of pimecrolimus cream 1% in mild to moderate head and neck atopic dermatitis of patients intolerant of topical corticosteroid. www.novartisclinicaltrials.com/clinicaltrialrepository/public/ login.jsp?target=%2Fclinicaltr (accessed 31th October 2006) 2006.
12. CASM981CUS03 2005 {unpublished data only} Novartis (protocol CASM981CUS03). A 6-month, randomized, multicenter, parallel-group, double-blind, vehicle-controlled study to evaluate the efficacy and safety of pimecrolimus 1% cream twice daily vs. standard of care in the management of mild to severe atopic dermatitis in adults. www.novartisclinicaltrials.com/ clinicaltrialrepository/public/login.jsp?target=%2Fclinicaltr (accessed 1st August 2006) 2005.
13. Eichenfield (a) 2002 {published and unpublished data} 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. Journal of the American Academy of Dermatology (http://www.fda.gov/cder/approval/index.htm) 2002 (accessed 1st November 2003);46(4):495-504.
14. Eichenfield (b) 2002 {published and unpublished data} 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. Journal of the American Academy of Dermatology (http://www.fda.gov/cder/approval/index.htm) 2002 (accessed 1st November 2003);46(4):495-504.
15. Ho 2003 {published data only} Ho VC, Gupta A, Kaufmann R, Todd G, Vanaclocha F, Takaoka R, Folster-Holst R, Potter P, Marshall K, et al.Safety and efficacy of non-steroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants. Journal of Pediatrics 2003;142(2): 155-62. [MEDLINE: 32].
16. Kapp 2002 {published data only} Kapp A, Papp K, Bingham A, Folster-Holst R, Ortonne JP, Potter PC, Gulliver W, Paul C, Molloy S, Barbier N, Thurston M, De Prost Y, Flare Reduction in Eczema with Elidel (infants) multicenter investigator study group. Long-term management of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid anti-inflammatory drug. Journal of Allergy and Clinical Immunology 2002;110(2):277-84. [MEDLINE: 194].
17. Kaufmann 2006 {published data only} Kaufmann R, Bieber T, Helgesen AL, Andersen BL, Luger T, Poulin Y, et al.Onset of pruritus relief with pimecrolimus cream 1% in adult patients with atopic dermatitis: a randomized trial. Allergy 2006;61(3):375-81.
18. Kempers 2004 {published data only} Kempers S, Boguniewicz M, Carter E, Jarrat M, Pariser D, Stewart D. Comparison of pimecrolimus cream 1% and tacrolimus ointment 0.03% in paediatric patients with atopic eczema. Journal of the European Academy of Dermatology and Venereology 2003;17:41.
19. * Kempers S, Boguniewicz M, Carter E, Jarratt M, Pariser D, Stewart D, et al.A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis. Journal of the American Academy of Dermatology 2004;51(4):515-25.
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