Treatment of infants with atopic eczema with pimecrolimus cream 1% improves parents' quality of life: A multicenter, randomized trial

Pediatric Allergy and Immunology

Volumn 16, Issue 6, 2005, Pages 527-533

  Staab, Doris ^a,d   Kaufmann, Roland ^b   Bräutigam, Matthias ^c   Wahn, Ulrich ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b GOETHE UNIVERSITY   (Germany)

^c NOVARTIS PHARMA GMBH   (Germany)

^d HUMBOLDT UNIVERSITY   (Germany)

Author keywords

Atopic eczema; Dermatitis; Elidel; Infants; Parents; Pimecrolimus cream 1 ; Quality of life

Indexed keywords

PIMECROLIMUS; PLACEBO;

ARTICLE; ATOPIC DERMATITIS; BURNING SENSATION; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COPING BEHAVIOR; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FEMALE; FOLLOW UP; HUMAN; INFANT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SKIN INFECTION; SLEEP DISORDER; SOCIAL LIFE; WELLBEING;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CHILD, PRESCHOOL; DERMATITIS, ATOPIC; DERMATOLOGIC AGENTS; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFANT; INFANT WELFARE; MALE; PARENTS; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; TACROLIMUS; TREATMENT OUTCOME;

EID: 26244453293     PISSN: 09056157     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1399-3038.2005.00306.x     Document Type: Article

References (28)

1. GIL KM, KEEFE FJ, SAMPSON HA, MCCASKILL CC, RODIN J, CRISSON JE. The relation of stress and family environment to atopic dermatitis symptoms in children. J Psychosom Res 1987: 31: 673-84.
2. PAULI-POTT U, DARUI A, BECKMANN D. Infants with atopic dermatitis: maternal hopelessness, child-rearing attitudes and perceived infant temperament. Psychother Psychosom 1999: 68: 39-45.
3. FINLAY AY. Quality of life impairment in atopic dermatitis and psoriasis. Clin Exp Perspect Sandimmun Ther 1992: 2: 10-11.
4. WARSCHBURGER P, BUCHHOLZ HT, PETERMANN F. Psychological adjustment in parents of young children with atopic dermatitis: which factors predict parental quality of life? Br J Dermatol 2004: 150: 304-11.
5. DAUD LR, GARRALDA ME, DAVID TJ. Psychosocial adjustment in preschool children with atopic eczema. Arch Dis Child 1993: 69: 670-6.
6. WIELAND S. Promoting health in children with atopic dermatitis. Nurse Pract 1998: 23: 86-90, 96-87.
7. FINLAY AY. Quality of life assessments in dermatology. Semin Cutan Med Surg 1998: 17: 291-6.
8. BEN-GASHIR MA. Relationship between quality of life and disease severity in atopic dermatitis/eczema syndrome during childhood. Curr Opin Allergy Clin Immunol 2003: 3: 369-73.
9. BEN-GASHIR MA, SEED PT, HAY RJ. Are quality of family life and disease severity related in childhood atopic dermatitis? J Eur Acad Dermatol Venereol 2002: 16: 455-62.
10. STAAB D, VON RÜDEN U, KEHRT R, WAHN U. The impact of childhood atopic dermatitis on quality of life of the family. Dermatol Psychosom 2000: 1: 173-178.
11. MEINGASSNER JG, GRASSBERGER M, FAHRNGRUBER H, MOORE HD, SCHUURMAN H, STUTZ A. A novel anti-inflammatory drug, SDZ ASM 981, for the topical and oral treatment of skin diseases: in vivo pharmacology. Br J Dermatol 1997: 137: 568-76.
12. 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: 501-7.
13. GRASSBERGER M, BAUMRUKER T, ENZ A, et al. A novel anti-inflammatory drug, SDZ ASM 981, for the treatment of skin diseases: in vitro pharmacology. Br J Dermatol 1999: 141: 264-73.
14. ZUBERBIER T, CHONG SU, GRUNOW K, et al. 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: 275-80.
15. 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.
16. HO VC, GUPTA A, KAUFMANN R, et al. Safety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants. J Pediatr 2003: 142: 155-62.
17. 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.
18. ADMINISTRATION UFaD. Guidance for industry. E6 good clinical practice: consolidated guidance. Federal Register 1997: 62: 25691-709
19. KAUFMANN R, FÖLSTER-HOLST R, HÖGER P, et al. Onset of action of pimecrolimus cream 1% in the treatment of atopic eczema in infants: A multicenter, randomized trial. J Allergy Clin Immunol 2004: 114: 1183-8.
20. SEYMOUR JL, KESWICK BH, HANIFIN JM, JORDAN WP, MILLIGAN MC. Clinical effects of diaper types on the skin of normal infants and infants with atopic dermatitis. J Am Acad Dermatol 1987: 17: 988-97.
21. MCKENNA SP, DOWARD LC, NIERO M, ERDMAN R. Development of needs-based quality of life instruments. Value Health 2004: 7 (Suppl. 1): S17-S21.
22. VON RÜDEN U, BUNIKOWSKI R, BRÄUTIGAM M, STAAB D. Cyclosporin A treatment of children with severe atopic dermatitis improves quality of life of their mothers. Dermatol Psychosom 2002: 3: 14-8.
23. Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task force on atopic dermatitis. Dermatology 1993: 186: 23-31.
24. KUNZ B, ORANJE AP, LABREZE L, STALDER JF, RING J, TAIEB A. Clinical validation and guidelines for the SCORAD index: consensus report of the European Task Force on Atopic Dermatitis. Dermatology 1997: 195: 10-19.
25. REID P, LEWIS-JONES MS. Sleep difficulties and their management in preschoolers with atopic eczema. Clin Exp Dermatol 1995: 20: 38-41.
26. HOLME SA, MAN I, SHARPE JL, DYKES PJ, LEWIS-JONES MS, FINLAY AY. The Children's Dermatology life quality index: validation of the cartoon version. Br J Dermatol 2003: 148: 285-90.
27. LEWIS-JONES MS, FINLAY AY. The children's dermatology life quality index (CDLQI): initial validation and practical use. Br J Dermatol 1995: 132: 942-9.
28. European Task Force on Atopic Dermatitis. Severity scoring of atopic dermatitis: the SCORAD index. Dermatology 1993: 186: 23-31.