Erythroleukoplakia of Mouth Clinical Trial
Official title:
A Prospective, Single-Arm, Open-Label, Phase II. Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-Pdt in Patients With Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia)
A Prospective, Single-Arm, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-pdt in Patients with Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia).
This is a single-center, single-arm, open-label study to evaluate the efficacy and safety of
topical Radion™-pdt for treatment of patients with oral verrucous hyperplasia (OVH) or oral
erythroleukoplakia (OEL).
Total duration of the study will be up to 40 weeks (from screening throughout study until
completion) as follows:
- Screening (within 2 weeks before dosing)
- Treatment period (up to 14 weeks)
- Safety follow-up period (within 2 weeks after final treatment)
- Follow-up period (final treatment plus 4 weeks, 8 weeks, 16 weeks and 24 weeks
respectively) All enrolled patients will receive up to 8 treatments (once every two
weeks) during a maximum of 14-week study treatment period. The treated lesion will be
clinically evaluated and documented (clinical photograph) at each treatment visit.
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