Pimecrolimus 1% cream in the treatment of facial psoriasis: A 16-week open label study Jacobi A et al. One of authors Braeutigam M belongs to clinical Research and Development, Novartis Pharma GmBH, Nuernberg. Dermatology 2008; 216:

Introduction Psoriasis affects 2-3% of the western population more frequent in the Northern Caucasian population. Psoriasis affects 2-3% of the western population more frequent in the Northern Caucasian population. It is characterized by accelerated proliferation and abnormal differentiation of epidermal keratinocytes. It is characterized by accelerated proliferation and abnormal differentiation of epidermal keratinocytes. Psoriasis has an immunological origin, caused by inappropriate activation of the cellular immune system with inflammatory infiltration of the affected epidermis and dermis with leucocytes macrophages and activated T-cells. Psoriasis has an immunological origin, caused by inappropriate activation of the cellular immune system with inflammatory infiltration of the affected epidermis and dermis with leucocytes macrophages and activated T-cells.

In a subset of psoriasis lesions extend beyond the hairline involving the forehead, neck ears and facial skin. In a subset of psoriasis lesions extend beyond the hairline involving the forehead, neck ears and facial skin. Patients with these lesions complain of intense itching and suffer from psychosocial problems. Patients with these lesions complain of intense itching and suffer from psychosocial problems. Long term treatment with topical corticosteroids [hydrocortisone not mentioned] is associated with telangiectasia, easy bruising, purpura, perioral dermatitis and atrophy. Usage on the face of topical steroids is therefore avoided. Long term treatment with topical corticosteroids [hydrocortisone not mentioned] is associated with telangiectasia, easy bruising, purpura, perioral dermatitis and atrophy. Usage on the face of topical steroids is therefore avoided.

Topical pimecrolimus (Elidel), a macrolactam ascomycin derivative works via calcineurin inhibition. It is effective in treating inflammatory disease and has gained approval for topical therapy of atopic dermatitis. Topical pimecrolimus (Elidel), a macrolactam ascomycin derivative works via calcineurin inhibition. It is effective in treating inflammatory disease and has gained approval for topical therapy of atopic dermatitis. Also effective in the treatment of plaque- type psoriasis under occlusion. Also effective in the treatment of plaque- type psoriasis under occlusion.

Methods 20 Patients (7female, 13 male) aged years old with plaque type psoriasis enrolled. 20 Patients (7female, 13 male) aged years old with plaque type psoriasis enrolled. Pimecrolimus 1% cream applied twice daily on the face for 8 weeks. Bland emollients were also allowed. Pimecrolimus 1% cream applied twice daily on the face for 8 weeks. Bland emollients were also allowed.

Assesment: -total symtom score(erythema and induration): 0 to 4 (4= very severe erythema and induration) -investigator’s total assessment (IGA): 0 to 5 (= very severe) -pruritus severity assessment: 0 to 3 (3= severe itching) -patient’s assessment score: 0 to 3 (3=uncontrolled disease) -DLQI (Dermatology Life quality index) : 0 to 30 : 0 to 1 =no, over 10=severe disturbance due to psoriasis or its treatment. Based on 10 questions: symptoms and impressions, disabilities in various daily activities, recreation, work, school and relationships, difficulties with treatment.

Patients were: -not allowed to have had systemic treatment for psoriasis 4 weeks prior to the study (Phtotherapy) -not allowed to have had systemic treatment for psoriasis 4 weeks prior to the study (Phtotherapy) -allowed to have emollients (5% urea in unguentum leniens) only the week priori to study. -allowed to have emollients (5% urea in unguentum leniens) only the week priori to study. Patients with an IGA above one were allowed low potency topical steroids, calcipotriol cream and salicylic acid cream except for the face. Patients with an IGA above one were allowed low potency topical steroids, calcipotriol cream and salicylic acid cream except for the face.

Results All patients showed improvement at 8 weeks following initiation of treatment and 16 weeks (8weeks after stopping the treatment) compared to baseline. All patients showed improvement at 8 weeks following initiation of treatment and 16 weeks (8weeks after stopping the treatment) compared to baseline.

Week 8: Week 8: -74.3% improvement of the total symptom score -65.5% of IGA -70.6% of pruritus severity -68.3% of patient’s assessment score -63.5% of DLQI Week 16 (8 weeks after stopping treatment): Week 16 (8 weeks after stopping treatment): -48.5% of total symptom score -39.7% of IGA -38.2% of pruritus severity -37.2% of patient’s assessment score -41.7% of DLQI

Discussion Pimecrolimus useful in atopic dermatitis Pimecrolimus useful in atopic dermatitis Not useful in plaque psoriasis because of thick scales Not useful in plaque psoriasis because of thick scales Useful in psoriasis of the face which psoriasis lesions are not covered with thick scales. Useful in psoriasis of the face which psoriasis lesions are not covered with thick scales. The authors hypothesizee that the effectiveness of pimecroliumus is due to better penetration in atopic skin. The authors hypothesizee that the effectiveness of pimecroliumus is due to better penetration in atopic skin. New galenical formulations are suggested by other studies with 10%urea as penetration enhancing. New galenical formulations are suggested by other studies with 10%urea as penetration enhancing.

Mechanism of action: psoriasis is considered to be a disorder of keratinocyte hyperproliferation in the epidermis, secondary to influx of activated T lymphocytes into the dermis. psoriasis is considered to be a disorder of keratinocyte hyperproliferation in the epidermis, secondary to influx of activated T lymphocytes into the dermis. As a result of the inhibition of the calcineurin pathway, there is selective inhibition of transcription and production of early Th1 cytokines such as Interleukin 2 or gamma- interferon in T lymphocytes as well as of the Th2 cytokines interleukin 4, 5 and 10. As a result of the inhibition of the calcineurin pathway, there is selective inhibition of transcription and production of early Th1 cytokines such as Interleukin 2 or gamma- interferon in T lymphocytes as well as of the Th2 cytokines interleukin 4, 5 and 10. This mode of action together with the low penetration through the skin could explain the specific anti-inflammatory activity of topically applied pimecrolimu in psoriatic skin with low potential for affecting the systemic immune response and no signe of inducing skin atrophy. This mode of action together with the low penetration through the skin could explain the specific anti-inflammatory activity of topically applied pimecrolimu in psoriatic skin with low potential for affecting the systemic immune response and no signe of inducing skin atrophy.