A randomized, single-blind, placebo-controlled, split-face study with pimecrolimus cream 1% for papulopustular rosacea.

BACKGROUND: Rosacea is a common inflammatory skin disorder for which the pathogenesis is unclear. Currently, there is no cure for rosacea, and it seems that standard therapies have focused mainly on minimizing inflammation. OBJECTIVES: The aim of this study is to investigate the potential efficacy, tolerability and safety profile of 1% pimecrolimus cream for the treatment of rosacea. METHODS: Twenty-five patients with papulopustular rosacea were enrolled to a randomized, single-blinded, placebo-controlled, split-face trial of pimecrolimus cream 1% consisting 4 week treatment and 2 week follow-up period. The patients were instructed to apply first the 'left side cream' labelled placebo cream (Ultrabase cream, Intendis GmbH, Berlin, Germany) to the left hemi-face then the 'right side cream' labelled 1% pimecrolimus cream (Elidel; Novartis Pharma, Nuremberg, Germany) to the right hemi-face, twice daily. They were informed to apply a standard amount of each cream with the fingertip-unit and not allowed to use any other agent concomittantly other than sunblock. Clinical evaluation and subjective severity assessment were obtained along with photographic documentation at baseline, first, second, and fourth weeks of the therapy and at the follow-up visit. Rosacea severity score for each sign of erythema, papules, pustules, oedema, and telengiectesia were graded from 0 to 3. Patients were questioned for the subjective symptoms, overall improvement on appearance and side-effects. RESULTS: Twenty-four patients completed the study with an exceptional compliance and tolerable safety profile. One patient withdrew from the study due to severe flare-up reaction affecting both hemi-faces. The mean baseline total rosacea severity scores were 5.06 + 1.29 for both sides and reduced to 2.5 +/- 1.06 vs. 3.25 +/- 1.24 on pimecrolimus vs. placebo applied sides without the significance (P = 0.06). There was not any significant difference concerning each rosacea sign scores and total rosacea severity scores except for the significant improvement in erythema score and total rosacea severity score obtained on the pimecrolimus-applied hemi-face at 2nd week of therapy (P =0.01 and P = 0.03, respectively). The reduction rates of the mean subjective severity scores at 4th week were 49.77% vs. 38.89% for pimecrolimus vs. placebo, respectively, without a statistical significance (P = 0.15). Subjective symptoms responded well in 54.16% of patients concerning pimecrolimus application compared with 12.50% for the placebo application. The side-effects were mostly transient local irritations. CONCLUSION: Our data implicated that pimecrolimus cream is not superior to placebo except for its efficacy on erythema. We believe that pimecrolimus cream can be a treatment option for rosacea patients with high erythema score for whom an initial accelerated improvement is needed. We believe further studies with topical pimecrolimus cream on larger study groups with different subtypes and severity of rosacea will clarify the potential effect of pimecrolimus cream for the treatment of rosacea.

Conjunctival impression cytology and tear-film changes in patients with psoriasis.

PURPOSE: In this study, we evaluated ocular-surface changes and tear-film functions in patients with plaque-type psoriasis. METHODS: This study was performed on two groups. Group I included 100 eyes of 50 subjects with chronic plaque-type psoriasis whose diagnoses were confirmed with skin biopsy. Group II included 100 eyes of 50 healthy volunteers who were in the same age and sex distribution. Ocular-surface changes were evaluated on the cell content of the surface conjunctival epithelium by conjunctival impression cytology and tear-film functions by the Schirmer I test and break-up time (BUT). RESULTS: Of the patients with psoriasis, 50% had a grade 0, 30% had a grade I, and 20% had a grade II conjunctival impression cytology differentiation compared with 95, 3, and 2%, respectively in the control group (p < 0.001). Snake-like appearance of nuclear chromatin in conjunctival epithelial cells was demonstrated in 12% of eyes in group I but in 2% of eyes in group II. The Schirmer's test results showed that average values were 10.1 +/- 5.8 mm in group I and 12.6 +/- 5.5 mm in group II (p > 0.001). The mean break-up time was 7.8 +/- 3.7 s in group I and 12.5 +/- 4.6 s in group II (p < 0.001). CONCLUSIONS: We showed the early conjunctival changes in patients with psoriasis. According to these results, primary etiologic factors may contribute to ocular lesions in psoriasis.