A randomized controlled trial of pimecrolimus cream 1% in adolescents and adults with head and neck atopic dermatitis and intolerant of, or dependent on, topical corticosteroids

British Journal of Dermatology

Volumn 157, Issue 5, 2007, Pages 954-959

  Murrell, D F ^a   Calvieri, S ^b   Ortonne, J P ^c   Ho, V C ^d   Weise Riccardi, S ^e   Barbier, N ^e   Paul, C F ^f  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b SAPIENZA UNIVERSITY OF ROME   (Italy)

^c CENTRE HOSPITALIER UNIVERSITAIRE DE NICE   (France)

^d UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^e NOVARTIS PHARMA AG   (Switzerland)

^f CHU PURPAN   (France)

Author keywords

Atopic dermatitis; Facial dermatoses; Pimecrolimus; Topical calcineurin inhibitors; Topical corticosteroids

Indexed keywords

CORTICOSTEROID; PIMECROLIMUS;

ABDOMINAL PAIN; ADULT; APPLICATION SITE DERMATITIS; APPLICATION SITE EDEMA; APPLICATION SITE ERYTHEMA; APPLICATION SITE IRRITATION; APPLICATION SITE PAIN; APPLICATION SITE PARESTHESIA; APPLICATION SITE PRURITUS; APPLICATION SITE REACTION; APPLICATION SITE SWELLING; ARTICLE; ATOPIC DERMATITIS; CLINICAL TRIAL; COMPARATIVE STUDY; CONJUNCTIVITIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DERMATITIS; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EPILUMINESCENCE MICROSCOPY; ERYTHEMA; EYELID PRURITUS; FEMALE; FLUSHING; FOOD ALLERGY; HEADACHE; HERPES SIMPLEX; HUMAN; INFLUENZA; MAJOR CLINICAL STUDY; MALE; PAIN; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SKIN ATROPHY; STATISTICAL SIGNIFICANCE; TELANGIECTASIA; UPPER RESPIRATORY TRACT INFECTION;

ADMINISTRATION, TOPICAL; ADOLESCENT; ADRENAL CORTEX HORMONES; ADULT; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; DERMATITIS, ATOPIC; DOUBLE-BLIND METHOD; FEMALE; HEAD; HUMANS; MALE; NECK; OINTMENTS; TACROLIMUS; TREATMENT OUTCOME;

EID: 35348838573     PISSN: 00070963     EISSN: 13652133     Source Type: Journal    
DOI: 10.1111/j.1365-2133.2007.08192.x     Document Type: Article

References (22)

1. Carroll CL, Balkrishnan R, Feldman SR et al. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol 2005 22:192 19.
2. Drake LA, Dinehart SM, Farmer ER et al. Guidelines of care for the use of topical glucocorticosteroids. American Academy of Dermatology. J Am Acad Dermatol 1996 35:615 9.
3. Kligman AM, Frosch PJ. Steroid addiction. Int J Dermatol 1979 18:23 31.
4. Rapaport MJ, Lebwohl M. Corticosteroid addiction and withdrawal in the atopic: the red burning skin syndrome. Clin Dermatol 2003 21:201 14.
5. Hengge UR, Ruzicka T, Schwarz RA, Cork MJ. Adverse effects of topical glucocorticosteroids. J Am Acad Dermatol 2006 54:1 15.
6. Stuetz A, Grassberger M, Meingassner JG. Pimecrolimus (Elidel, SDZ ASM 981) - preclinical pharmacologic profile and skin selectivity. Semin Cutan Med Surg 2001 20:233 41.
7. Allen BR, Lakhanpaul M, Morris A et al. Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients. Arch Dis Child 2003 88:969 73.
8. Van Leent EJ, Ebelin ME, Burtin P et al. Low systemic exposure after repeated topical application of pimecrolimus (Elidel, SDZ ASM 981) in patients with atopic dermatitis. Dermatology 2002 204:63 8.
9. Queille-Roussel C, Paul C, Duteil L 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 13.
10. Hanifin J, Rajka G. Diagnostic criteria for atopic dermatitis. Acta Derm Venereol (Stockh) 1980 92 (Suppl. 44 7.
11. Eichenfield LF, Lucky AW, Boguniewicz M 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. Hanifin JM, Thurston M, Omoto M et al. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol 2001 10:11 18.
13. Barbier N, Paul C, Luger T et al. Validation of the Eczema Area and Severity Index for atopic dermatitis in a cohort of 1550 patients from the pimecrolimus cream 1% randomized controlled clinical trials programme. Br J Dermatol 2004 150:96 102.
14. Freeman AK, Serle J, Van Veldhuisen P et al. Tacrolimus ointment in the treatment of eyelid dermatitis. Cutis 2004 73:267 71.
15. Frosch PJ, Behrenbeck EM, Frosch K, Macher E. The Duhring chamber assay for corticosteroid atrophy. Br J Dermatol 1981 104:57 65.
16. Sahni D, Darley CR, Hawk JL. Glaucoma induced by periorbital topical steroid use - a rare complication. Clin Exp Dermatol 2004 29:617 19.
17. thoe Schwartzenberg GW, Buys YM. Glaucoma secondary to topical use of steroid cream. Can J Ophthalmol 1999 34:222 5.
18. Nivenius E, van der Ploeg I, Jung K et al. Tacrolimus ointment vs steroid ointment for eyelid dermatitis in patients with atopic keratoconjunctivitis. Eye 2007 21:968 75.
19. Kao JS, Fluhr JW, Man MQ et al. Short-term glucocorticoid treatment compromises both permeability barrier homeostasis and stratum corneum integrity: inhibition of epidermal lipid synthesis accounts for functional abnormalities. J Invest Dermatol 2003 120:456 64.
20. Sheu HM, Lee JYY, Chai CY, Kuo KW. Depletion of stratum corneum intercellular lipid lamellae and barrier function abnormalities after long-term topical corticosteroids. Br J Dermatol 1997 136:884 90.
21. Kyllönen H, Remitz A, Mandelin JM et al. Effect of 1-year intermittent treatment with topical tacrolimus monotherapy on skin collagen synthesis in patients with atopic dermatitis. Br J Dermatol 2004 150:1174 81.
22. Caproni M, Torchia D, Antiga E et al. The effects of tacrolimus ointment on regulatory T lymphocytes in atopic dermatitis. J Clin Immunol 2006 26:370 5.