Drug intelligence / Profile preview

Placebo Gel (Dermax SA)

Development stage
Unknown
Lead developer
Dermax
Administration
Topical
01

Overview

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.

Other names
Placebo Gelplaceo gel-Dermax SA-external anogenital warts

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