A Phase 2 interventional study of SB208 2% and SB208 4% in Tinea Pedis, sponsored by Novan, Inc.. Completed at 1 site in Dominican Republic. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-10.
Sponsored by Novan, Inc. · Phase 2, Interventional, and Treatment
This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in non immunocompromised adult subjects with interdigital tinea pedis.
A phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the interdigital areas and all affected and immediate surrounding areas of one or both feet once daily for 2 weeks, followed by a 4-week post-treatment observation period.
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 222 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →Novan, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Apply once daily to one or both feet for 14 days
Drug: SB208 2%
Apply once daily to one or both feet for 14 days
Drug: SB208 4%
Apply once daily to one or both feet for 14 days
Drug: SB208 16%
Apply once daily to one or both feet for 14 days
Drug: Vehicle Gel
Apply once daily to one or both feet for 14 days
Also known as: NVN1000 4%
Apply once daily to one or both feet for 14 days
Also known as: NVN1000 8%
Apply once daily to one or both feet for 14 days
Also known as: NVN1000 32%
Apply once daily to one or both feet for 14 days
Also known as: Vehicle
Fungal culture result
Negative fungal culture from target lesion
Time frame: 2 weeks
Clinical cure
Amelioration of signs and symptoms of tinea pedis
Time frame: 6 wks
Mycological cure
No evidence of fungal infection based on skin scraping and culture
Time frame: 6 wks
Incidence of treatment-emergent adverse events
Summary of treatment emergent adverse events by treatment group
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Berdazimer sodium