A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis

• Published in: Journal of the American Academy of Dermatology Vol. 51; no. 4; pp. 515 - 525
• Main Authors: Kempers, Steven, Boguniewicz, Mark, Carter, Eric, Jarratt, Michael, Pariser, David, Stewart, Dan, Stiller, Matt, Tschen, Eduardo, Chon, Katie, Wisseh, Steve, Abrams, Beatrice
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.10.2004; Elsevier
• Subjects: Adolescent; Allergic diseases; Biological and medical sciences; Child; Child, Preschool; Dermatitis, Atopic - drug therapy; Dermatitis, Irritant - etiology; Dermatologic Agents - administration & dosage; Dermatologic Agents - adverse effects; Dermatology; Drug Administration Schedule; Drug Combinations; Erythema - chemically induced; Female; Humans; Immunopathology; Male; Medical sciences; Ointments; Patient Satisfaction; Pruritus - chemically induced; Skin allergic diseases. Stinging insect allergies; Tacrolimus - administration & dosage; Tacrolimus - adverse effects; Tacrolimus - analogs & derivatives; Human; Allergy; Immunopathology; Skin disease; Pimecrolimus; Dermatology; Cream; Lactone; Ointment; Macrolide; Atopy; Local administration; Randomization; Treatment; Tacrolimus; Atopic dermatitis; Clinical trial; Immunosuppressive agent; Child; Comparative study
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2004.01.051

To evaluate pimecrolimus cream 1% and tacrolimus ointment 0.03% in pediatric patients with moderate atopic dermatitis (AD). 141 patients (aged 2-17 years) were randomized to treatment with pimecrolimus cream 1% (n = 71) or tacrolimus ointment 0.03% (n = 70) twice daily for 6 weeks. At day 4, local, application-site reactions were less common and of shorter duration with pimecrolimus than with tacrolimus. Incidence of erythema/irritation was 8% (6/71) with pimecrolimus compared with 19% (13/70) with tacrolimus ( P = .039). Fewer patients receiving pimecrolimus (0%, 0/6) experienced erythema/irritation lasting >30 minutes, compared with those receiving tacrolimus (85%, 11/13; P < .001). Fewer patients reported itching with pimecrolimus (8%; 6/71) than with tacrolimus (20%; 14/70; P = .073). Incidence of warmth, stinging, and burning was similar in both groups; however, reactions lasting >30 minutes were fewer with pimecrolimus (0%, 0/14) than with tacrolimus (67%, 8/12; P < .001). More patients receiving pimecrolimus rated ease of application as ‘excellent’ or ‘very good’, compared with tacrolimus (76% vs 59%, respectively; P < .020). Efficacy was similar in both groups at day 43. Both treatments were generally well tolerated with no unexpected adverse events. Pimecrolimus cream 1% had better formulation attributes and local tolerability than tacrolimus ointment 0.03% while providing similar efficacy and overall safety in pediatric patients with moderate AD.