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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.
Br J Dermatol 2007; 157(5):954-9BJ

Abstract

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.

Authors+Show Affiliations

Department of Dermatology, St George Hospital, University of NSW, Sydney, Australia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17935515

Citation

Murrell, D F., et al. "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." The British Journal of Dermatology, vol. 157, no. 5, 2007, pp. 954-9.
Murrell DF, Calvieri S, Ortonne JP, et al. 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. Br J Dermatol. 2007;157(5):954-9.
Murrell, D. F., Calvieri, S., Ortonne, J. P., Ho, V. C., Weise-Riccardi, S., Barbier, N., & Paul, C. F. (2007). 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. The British Journal of Dermatology, 157(5), pp. 954-9.
Murrell DF, et al. 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. Br J Dermatol. 2007;157(5):954-9. PubMed PMID: 17935515.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Murrell,D F, AU - Calvieri,S, AU - Ortonne,J P, AU - Ho,V C, AU - Weise-Riccardi,S, AU - Barbier,N, AU - Paul,C F, PY - 2007/10/16/pubmed PY - 2008/4/9/medline PY - 2007/10/16/entrez SP - 954 EP - 9 JF - The British journal of dermatology JO - Br. J. Dermatol. VL - 157 IS - 5 N2 - 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. SN - 0007-0963 UR - https://www.unboundmedicine.com/medline/citation/17935515/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_ L2 - https://doi.org/10.1111/j.1365-2133.2007.08192.x DB - PRIME DP - Unbound Medicine ER -