A Phase 3 interventional study of Vehicle versus NB-001 in Recurrent Herpes Simplex Labialis, sponsored by NanoBio Corporation. Completed at 35 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-23.
Sponsored by NanoBio Corporation · Phase 3, Interventional, and Treatment
Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).
This is a randomized, double-blind, two arm, parallel-group, vehicle-controlled, multi-center study of NB-001. The study is designed to demonstrate the safety and efficacy of NB-001 in subjects with RHL. Approximately 850 subjects who meet all eligibility criteria will be randomized in the study. Subjects will begin treatment as soon as they experience the onset of cold sore symptoms. Treatment will be applied 5 times daily, approximately 3-4 hours apart while awake. Treatment will continue until the investigator assesses the primary lesion complex as healed or a maximum of 4 days.
Clinic visits will occur on a daily basis until the investigator determines that the primary lesion complex has healed or a maximum of 15 clinic visits. At daily clinic visits, the investigator will make efficacy assessments of the primary lesion complex; safety and tolerability assessments of NB-001 following topical administration will also be assessed daily. Subjects will make daily assessments of therapy.
At the End of Study, the investigator will make a global assessment of therapy. The subject will make global assessments of therapy and social impact.
305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.
This study's enrollment of 907 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →NanoBio Corporation is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Vehicle
Drug: Vehicle versus NB-001
Active NB-001(0.3%)
Drug: Vehicle versus NB-001
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Time of Healing of the primary lesion complex
Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator. Time to healing is the time from application of the first dose to investigator assessed healing
Time frame: Days
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage.
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. This analysis will be performed in the cohort of subjects whose primary lesion complex is assessed as being in the Prodrome (pain, burning, tingling, itching, redness, swelling, or a tight sensation of the lip), Erythema/Macule, Papule/Edema, or Aborted Stage by the investigator at the first post-treatment visit.
Time frame: First Post-Treatment Visit
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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