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

• Published in: British journal of dermatology (1951) Vol. 157; no. 5; pp. 954 - 959
• Main Authors: Murrell, D.F., Calvieri, S., Ortonne, J.P., Ho, V.C., Weise-Riccardi, S., Barbier, N., Paul, C.F.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-11-2007; Blackwell
• Subjects: Administration, Topical; Adolescent; Adrenal Cortex Hormones - adverse effects; Adult; Allergic diseases; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; atopic dermatitis; Biological and medical sciences; Dermatitis, Atopic - drug therapy; Dermatology; Double-Blind Method; facial dermatoses; Female; Head; Humans; Immunopathology; Male; Medical sciences; Neck; Ointments; pimecrolimus; Skin allergic diseases. Stinging insect allergies; Tacrolimus - analogs & derivatives; Tacrolimus - therapeutic use; topical calcineurin inhibitors; topical corticosteroids; Treatment Outcome; Allergy; Skin disease; Pimecrolimus; Calcineurin inhibitor; topical corticosteroids; Cream; Atopy; Local administration; Randomization; Atopic dermatitis; Head and neck; facial dermatoses; Adult; Clinical trial; topical calcineurin inhibitors; Protein synthesis inhibitor; Face; Human; Immunopathology; Corticosteroid; Dermatology; Macrolide; Immunomodulator; Adolescent; Immunosuppressive agent
• ISSN: 0007-0963; 1365-2133
• DOI: 10.1111/j.1365-2133.2007.08192.x

Summary
Background  There is a need for alternative treatments for atopic dermatitis (AD) of the face and neck as long‐term use of topical corticosteroids (TCS) is associated with skin atrophy and telangiectasia and some patients develop allergy, intolerance or other side‐effects.
Objectives  This study was designed to assess the efficacy and safety of pimecrolimus cream 1% in patients with AD of the face and neck who are either dependent on, or intolerant of, TCS.
Methods  A 12‐week study comprising a 6‐week, double‐blind, randomized, vehicle‐controlled phase was conducted, followed by a 6‐week, open‐label phase. Two hundred patients aged 12 years or over with mild to moderate head and neck AD, intolerant of, or dependent on, TCS were randomized to either pimecrolimus cream or vehicle cream. The primary efficacy criterion was the facial investigator’s global assessment score at 6 weeks. Secondary efficacy criteria were head and neck Eczema Area and Severity Index (EASI), pruritus score and eyelid dermatitis. Facial skin atrophy and telangiectasia were assessed with dermatoscopy.
Results  A significantly higher percentage of patients treated with pimecrolimus was cleared or almost cleared of facial AD compared with vehicle (47% vs. 16%, respectively). A statistically significant difference was also seen on head and neck EASI and pruritus score. Significantly more pimecrolimus‐treated patients than vehicle‐treated patients achieved clearance of eyelid dermatitis (45% vs. 19%, respectively). Among the 77 patients with skin atrophy at baseline, treatment with pimecrolimus was associated with a reversal in skin thinning. Of the 112 patients with telangiectasia at baseline, no statistically significant difference was seen between treatment groups. Adverse events occurred with similar frequency in both groups.
Conclusion  Pimecrolimus cream 1% is effective in patients with head and neck dermatitis intolerant of, or dependent on, TCS. Reversion of skin atrophy may occur during TCS‐free intervals.