EFFICACY AND SAFETY OF ELICA-MTM CREAM (MOMETASONE FUROATE 0.1% W/W AND MICONAZOLE NITRATE 2% W/W) IN NAPKIN DERMATITIS OR DERMATITIS CAUSED BY INFECTION WITH CERTAIN FUNGI AND BACTERIA IN CHILDREN ZERO TO THREE YEARS OF AGE AN OPEN-LABEL, PHASE IV, MULTI

Eman AlMukhadeb* and Hend AlOtaibi

ABSTRACT

Background: Napkin dermatitis is a skin condition that affects the area under a baby's diaper. It is a very common dermatological disease in infants and children, mainly caused by excess moisture of the skin, or prolonged contact with urine and feces. Objective: Our study aimed to assess the efficacy and safety of Elica-MTM cream in children with napkin dermatitis with inflamed skin conditions of eczema or dermatitis caused by fungal and bacterial infections. Methods: This was an open-label, single-arm, phase IV study to evaluate the safety and efficacy of Elica-MTM cream in 69 children with napkin dermatitis with inflamed skin conditions of eczema or dermatitis caused by infection with certain fungi and bacteria. We conducted our study at two centers in the Kingdom of Saudi Arabia. All enrolled subjects were treated for 14 days and followed up for efficacy and safety assessments. Results: Efficacy evaluation showed that around 90% of patients had more than 50% reduction in the signs of erythema and pruritus. Meanwhile, evaluation of severity showed that at the baseline visit, the grades were 29%, 66.7% and 4.3% for mild, moderate, and severe, respectively. Finally, only two patients experienced moderate adverse events; not serious and were found to be unrelated to the study medication. Conclusion: The evaluation of the efficacy of Elica-MTM cream showed a substantial reduction in the signs and symptoms of erythema and pruritus. Additionally, the two moderate, adverse events reported indicate the high safety feature of Elica-MTM cream.

Keywords: Elica-MTM Cream, Napkin Dermatitis, Dermatitis, Eczema, Mometasone Furoate, Miconazole Nitrate.