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Tacrolimus ointment is effective for facial and intertriginous psoriasis.

Abstract

BACKGROUND

Intertriginous and facial involvement are manifestations of psoriasis that require a different approach than is used for typical plaque psoriasis on other skin areas. Topical corticosteroids are the primary treatment for psoriasis; however, the side effects of corticosteroids are magnified on intertriginous and facial skin. Topical tacrolimus offers the potential for anti-inflammatory effect without the atrophy or other local side effects associated with the use of topical corticosteroids.

OBJECTIVE

To determine the efficacy and tolerability of 0.1% tacrolimus ointment for the treatment of facial or intertriginous psoriasis.

METHODS

One hundred sixty-seven patients 16 years or older were evaluated in an 8-week, randomized, double-blind, vehicle-controlled, multi-center study. Upon entry into the study, patients were randomized 2:1 to apply the tacrolimus ointment 0.1% or vehicle twice daily to all psoriatic lesions of the face or intertriginous areas for 8 weeks. The physician's global assessment was used to assess improvement from baseline. The inverse psoriasis severity for patients was measured using a 6-point scale from clear to very severe.

RESULTS

As early as day 8, more patients ( P = .004) had cleared or achieved excellent improvement in the 0.1% tacrolimus ointment group compared to the vehicle group (24.8% vs 5.8%). At the end of the 8-week treatment period 65.2% of the tacrolimus ointment group and 31.5% of the vehicle were clear or almost clear ( P < .0001) based on a Static Severity Score. Adverse events were similar in the 0.1% tacrolimus ointment and vehicle groups. Conclusion Tacrolimus ointment is an effective treatment for psoriasis of the face or intertriginous areas.

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  • Authors+Show Affiliations

    ,

    Mt. Sinai School of Medicine, New York, New York, USA.

    , , , , ,

    Source

    MeSH

    Adolescent
    Adult
    Dermatologic Agents
    Double-Blind Method
    Facial Dermatoses
    Female
    Humans
    Immunosuppressive Agents
    Male
    Middle Aged
    Ointments
    Psoriasis
    Tacrolimus

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    15523350

    Citation

    Lebwohl, Mark, et al. "Tacrolimus Ointment Is Effective for Facial and Intertriginous Psoriasis." Journal of the American Academy of Dermatology, vol. 51, no. 5, 2004, pp. 723-30.
    Lebwohl M, Freeman AK, Chapman MS, et al. Tacrolimus ointment is effective for facial and intertriginous psoriasis. J Am Acad Dermatol. 2004;51(5):723-30.
    Lebwohl, M., Freeman, A. K., Chapman, M. S., Feldman, S. R., Hartle, J. E., & Henning, A. (2004). Tacrolimus ointment is effective for facial and intertriginous psoriasis. Journal of the American Academy of Dermatology, 51(5), pp. 723-30.
    Lebwohl M, et al. Tacrolimus Ointment Is Effective for Facial and Intertriginous Psoriasis. J Am Acad Dermatol. 2004;51(5):723-30. PubMed PMID: 15523350.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Tacrolimus ointment is effective for facial and intertriginous psoriasis. AU - Lebwohl,Mark, AU - Freeman,Amy Krupnick, AU - Chapman,M Shane, AU - Feldman,Steven R, AU - Hartle,Jennifer E, AU - Henning,Alice, AU - ,, PY - 2004/11/4/pubmed PY - 2005/5/17/medline PY - 2004/11/4/entrez SP - 723 EP - 30 JF - Journal of the American Academy of Dermatology JO - J. Am. Acad. Dermatol. VL - 51 IS - 5 N2 - BACKGROUND: Intertriginous and facial involvement are manifestations of psoriasis that require a different approach than is used for typical plaque psoriasis on other skin areas. Topical corticosteroids are the primary treatment for psoriasis; however, the side effects of corticosteroids are magnified on intertriginous and facial skin. Topical tacrolimus offers the potential for anti-inflammatory effect without the atrophy or other local side effects associated with the use of topical corticosteroids. OBJECTIVE: To determine the efficacy and tolerability of 0.1% tacrolimus ointment for the treatment of facial or intertriginous psoriasis. METHODS: One hundred sixty-seven patients 16 years or older were evaluated in an 8-week, randomized, double-blind, vehicle-controlled, multi-center study. Upon entry into the study, patients were randomized 2:1 to apply the tacrolimus ointment 0.1% or vehicle twice daily to all psoriatic lesions of the face or intertriginous areas for 8 weeks. The physician's global assessment was used to assess improvement from baseline. The inverse psoriasis severity for patients was measured using a 6-point scale from clear to very severe. RESULTS: As early as day 8, more patients ( P = .004) had cleared or achieved excellent improvement in the 0.1% tacrolimus ointment group compared to the vehicle group (24.8% vs 5.8%). At the end of the 8-week treatment period 65.2% of the tacrolimus ointment group and 31.5% of the vehicle were clear or almost clear ( P < .0001) based on a Static Severity Score. Adverse events were similar in the 0.1% tacrolimus ointment and vehicle groups. Conclusion Tacrolimus ointment is an effective treatment for psoriasis of the face or intertriginous areas. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/15523350/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190962204018961 DB - PRIME DP - Unbound Medicine ER -