NCT02860052

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 10, 2019

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

August 2, 2016

Last Update Submit

January 8, 2019

Conditions

Tinea Pedis

Outcome Measures

Primary Outcomes (1)

  • Fungal culture result

    Negative fungal culture from target lesion

    2 weeks

Secondary Outcomes (2)

  • Clinical cure

    6 wks

  • Mycological cure

    6 wks

Other Outcomes (1)

  • Incidence of treatment-emergent adverse events

    6 weeks

Study Arms (4)

SB208 2%

EXPERIMENTAL

Apply once daily to one or both feet for 14 days

Drug: SB208 2%

SB208 4%

EXPERIMENTAL

Apply once daily to one or both feet for 14 days

Drug: SB208 4%

SB208 16%

EXPERIMENTAL

Apply once daily to one or both feet for 14 days

Drug: SB208 16%

Vehicle Gel

PLACEBO COMPARATOR

Apply once daily to one or both feet for 14 days

Drug: Vehicle Gel

Interventions

SB208 2%DRUG

Apply once daily to one or both feet for 14 days

Also known as: NVN1000 4%
SB208 2%
SB208 4%DRUG

Apply once daily to one or both feet for 14 days

Also known as: NVN1000 8%
SB208 4%
SB208 16%DRUG

Apply once daily to one or both feet for 14 days

Also known as: NVN1000 32%
SB208 16%
Vehicle GelDRUG

Apply once daily to one or both feet for 14 days

Also known as: Vehicle
Vehicle Gel

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Otherwise healthy male and female subjects with clinical diagnosis of interdigital t. pedis
  • T.pedis provisionally confirmed at baseline by a positive KOH wet mount for segmented fungal hyphae on skin scraping from the target site

You may not qualify if:

  • Women who are pregnant or nursing or planning on becoming pregnant
  • Subjects with onychomycosis or moccasin-type t. pedis
  • Subjects using topical or systemic anti-fungal agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Dermatológico y Cirugía de Piel,

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousFoot DermatosesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPruritusSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • M Joyce Rico, MD

    Novan, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 9, 2016

Study Start

July 19, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

January 10, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

DO(1)