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Placebo Gel (Dermax SA) is an inactive topical formulation used as the control arm in a Phase 3 multicenter, randomized, double-blind bioequivalence study (NCT03532776). The trial, sponsored by Dermax SA in collaboration with Hyloris Developments, was designed to compare a generic Podofilox Gel 0.5% formulation to the reference product Condylox Gel 0.5% (manufactured by Allergan) for the treatment of external anogenital warts (perianal and/or external genital warts) caused by human papillomavirus (HPV). The placebo gel contains no active pharmaceutical ingredient and is formulated to match the physical characteristics (appearance and consistency) of the active podofilox gel to maintain the integrity of the blinding process. Its primary function in the study was to serve as a baseline for evaluating the total disappearance of warts within treated areas at 28 days.
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