Pimecrolimus 1% cream in the treatment of cutaneous lesions of pemphigus
vulgaris: a double-blind, placebo-controlled clinical trial.
Author(s): Iraji F, Asilian A, Siadat AH.
Affiliation(s): Department of Dermatology, Isfahan University of Medical Sciences Skin Diseases
and Leishmaniasis Research Center, Isfahan, Iran.
Publication date & source: 2010, J Drugs Dermatol. , 9(6):684-6
BACKGROUND: Pemphigus vulgaris (PV) is a chronic, bullous disorder that is
usually characterized by the presence of bulla and erosion on the skin and
mucosa. Many studies on PV focus on the use of topical non-steroid agents. One of
these agents is pimecrolimus; its efficacy is established in some inflammatory
and autoimmune disorders such as oral and genital lichen planus.
PATIENTS, MATERIALS AND METHODS: This was a double-blind study that was performed
in 11 patients with confirmed diagnosis of PV. Patients under treatment with
systemic steroid and azathioprine who had bilateral symmetrical oral lesions were
selected and right- or left-sided lesions of those identified were randomized to
be treated either by pimecrolimus 1% cream or placebo. The largest diameter of
lesions was measured at the baseline and every 15 days for two times.
Epithelization Index (EI) was calculated and data were analyzed with a program
for statistical analysis.
RESULTS: Overall, 11 patients (62 cutaneous lesions; 31 lesions in the
pimecrolimus group and 31 lesions in the placebo group) with cutaneous lesions of
the pemphigus vulgaris were included in this study. At the end of day 15, there
was significant difference regarding EI between the pimecrolimus and placebo
groups. In addition, EI was significantly different at the end of study (day 30)
in favor of pimecrolimus group (P = 0.000).
CONCLUSION: Pimecrolimus can be used as an effective and safe adjunctive
treatment for cutaneous lesions of pemphigus vulgaris.
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