761
Participants
Start Date
October 8, 2020
Primary Completion Date
May 31, 2023
Study Completion Date
May 31, 2023
HDIT101 (blinded therapy)
Patients will be treated with with topical HDIT101 (twice daily for 2 days). Blinded study drug will be applied to the first 2 lesions occuring in the treatment phase.
Placebo (blinded therapy)
Patients will be treated with with topical placebo (twice daily for 2 days). Blinded study drug will be applied to the first 2 lesions occuring in the treatment phase.
Photo documentation of orolabial herpes lesions
Patients will be asked to document their orolabial lesions with photos by using their smart phone
Completion of questionnaires (patient-reported outcomes)
Patients will be asked to document their health status in questionnaires by using their smart phone
28-day swabbing of orolabial region
Patients will be asked to complete 3 episodes of 28-day swabbing of orolabial lesions
Blood drawings
Blood will be drawn for e.g. safety lab, HSV-analysis, pharmacokinetic etc.
emovis GmbH, Berlin
bioskin Prüfzentrum, Hamburg
ICH Study Center GmbH & Co. KG, Hamburg
Infektio Research GmbH & Co. KG, Frankfurt am Main
Universitätsklinikum Heidelberg - Medizinische Klinik, Klinische Pharmakologie & Pharmakoepidemiologie, Heidelberg
Lead Sponsor
Heidelberg ImmunoTherapeutics GmbH
INDUSTRY