BACKGROUND: Data on the efficacy of pimecrolimus cream 1% within the first days of treatment are scarce, as in previous studies, the first postbaseline assessment was performed only after 1 week. OBJECTIVE: We sought to investigate the onset of action of pimecrolimus cream 1% in infants with mild to very severe atopic eczema. METHODS: We used pimecrolimus cream 1% (n = 129) or vehicle cream (n = 66) administered in a double-blind manner for 4 weeks and then open-label pimecrolimus cream 1% for 12 weeks, with a 4-week follow-up period. RESULTS:Pimecrolimus cream 1% reduced the mean Eczema Area and Severity Index at 4 weeks by 71.5% compared with an increase of 19.4% with vehicle ( P < .001). The reduction in the Eczema Area and Severity Index with pimecrolimus cream 1% was significant at day 4 (38.5% vs 17.6% increase with vehicle). Significant improvements in caregivers' assessments of pruritus and sleep loss were observed with pimecrolimus cream 1% by day 2 ( P < .03) and day 3 ( P = .002), respectively, compared with vehicle. Responses to pimecrolimus cream 1% were sustained during the open-label phase, and pimecrolimus cream 1% was well tolerated. Symptoms of atopic eczema returned gradually after discontinuation. CONCLUSION:Pimecrolimus cream 1% was well tolerated and effective in patients with mild to very severe atopic eczema, with rapid onset of action and no disease rebound after discontinuation.
RCT Entities:
BACKGROUND: Data on the efficacy of pimecrolimuscream 1% within the first days of treatment are scarce, as in previous studies, the first postbaseline assessment was performed only after 1 week. OBJECTIVE: We sought to investigate the onset of action of pimecrolimuscream 1% in infants with mild to very severe atopic eczema. METHODS: We used pimecrolimuscream 1% (n = 129) or vehicle cream (n = 66) administered in a double-blind manner for 4 weeks and then open-label pimecrolimuscream 1% for 12 weeks, with a 4-week follow-up period. RESULTS:Pimecrolimuscream 1% reduced the mean Eczema Area and Severity Index at 4 weeks by 71.5% compared with an increase of 19.4% with vehicle ( P < .001). The reduction in the Eczema Area and Severity Index with pimecrolimuscream 1% was significant at day 4 (38.5% vs 17.6% increase with vehicle). Significant improvements in caregivers' assessments of pruritus and sleep loss were observed with pimecrolimuscream 1% by day 2 ( P < .03) and day 3 ( P = .002), respectively, compared with vehicle. Responses to pimecrolimuscream 1% were sustained during the open-label phase, and pimecrolimuscream 1% was well tolerated. Symptoms of atopic eczema returned gradually after discontinuation. CONCLUSION:Pimecrolimuscream 1% was well tolerated and effective in patients with mild to very severe atopic eczema, with rapid onset of action and no disease rebound after discontinuation.
Authors: Lynda Schneider; Jon Hanifin; Mark Boguniewicz; Lawrence F Eichenfield; Jonathan M Spergel; Rada Dakovic; Amy S Paller Journal: Pediatr Dermatol Date: 2016-06-07 Impact factor: 1.588
Authors: Thomas Luger; Mark Boguniewicz; Warner Carr; Michael Cork; Mette Deleuran; Lawrence Eichenfield; Philippe Eigenmann; Regina Fölster-Holst; Carlo Gelmetti; Harald Gollnick; Eckard Hamelmann; Adelaide A Hebert; Antonella Muraro; Arnold P Oranje; Amy S Paller; Carle Paul; Luis Puig; Johannes Ring; Elaine Siegfried; Jonathan M Spergel; Georg Stingl; Alain Taieb; Antonio Torrelo; Thomas Werfel; Ulrich Wahn Journal: Pediatr Allergy Immunol Date: 2015-04-13 Impact factor: 6.377
Authors: Susanna M Kannenberg; Sarah Karabus; Willem I Visser; Jamilabibi Aboobaker; Magdalena M Kriel; Michael Levin; Basil Magigaba; Ahmed Manjra; Rupesh Misra; Pholile Mpofu; Azwitamisi Tshigabe; Thomas Luger Journal: S Afr Fam Pract (2004) Date: 2020-11-23