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miconazole + diclofenac + urea is a topical combination gel formulation developed by William N. Handelman for the treatment of onychomycosis (fungal nail infection). The therapeutic rationale for this combination involves the synergistic action of three components: miconazole, an imidazole antifungal that inhibits the synthesis of ergosterol in fungal cell membranes; diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) that may enhance antifungal efficacy or penetration; and urea, a keratolytic agent that softens the nail plate to facilitate the delivery of the active drugs to the underlying nail bed. The formulation was evaluated in a Phase 2 clinical trial (NCT01041300), known as the Dr. Bill Antifungal Nail Gel Study, which primarily investigated the systemic absorption of diclofenac sodium and the safety profile of the gel in patients with onychomycosis.
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