Comparison of Clinical Efficacy of Topical Pimecrolimus with Betamethasone in Chronic Skin Lesions Due to Sulfur Mustard Exposure: A Randomized,Investigator‐Blind Study

Abstract: This study compared topical pimecrolimus with betamethasone in the treatment of pruritus and chronic skin lesions due to sulfur mustard exposure. Seventy male chemical‐injured war veterans participated in this investigator‐blinded clinical trial. They were randomized to receive pimecrolimus cream 1% (n = 35) or betamethasone cream 0.1% (n = 35) two times a day for 6 weeks. Dermatological examination and assessment of pruritus severity by a pruritic score questionnaire and visual analogue scale were done before and after the treatment course. A significant decrease (P < 0.05) in pruritus, burning sensation, and skin dryness was shown in both groups after the treatment. However, the severity of hyper‐ and hypopigmentation, vesicle, erythema, fissure, lichenification and excoriation did not decrease significantly in either group (P > 0.05). Mean (± standard deviation) pruritic scores at baseline for the pimecrolimus and betamethasone groups were 30.4 (± 8.0) and 33.6 (± 7.2), respectively (P = 0.103). These scores decreased to 18.8 (± 4.8) in the pimecrolimus and 20.8 (± 4.0) in the betamethasone groups after treatment; both showed a statistically significant decrease (P < 0.001). Change of pruritus score from baseline to after the treatment course was not statistically different between the two groups (P = 0.502). No serious side‐effects were reported during the course of the treatment. Topical pimecrolimus 1% was as effective as betamethasone cream 0.1% in controlling pruritus, burning sensation and skin dryness of sulfur mustard‐exposed patients.