Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
DermBiont, Inc.
Age
18–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 to 50 years of age, inclusive, at Screening
Willing to abstain from all cosmetic activities involving the toenails during the entire course of the study
Distal subungual onychomycosis defined as a great toenail with onycholysis and thickening of the nail bed with keratinous material
Willing to have his/her treatment-targeted great toenail(s) clipped to remove onycholytic nail plate at each visit
At least one treatment-targeted great toenail must have at least 6 mm of clear nail from the proximal nail fold to the proximal limit of disease and, after trimming to within 1mm distal nail groove, have at least 3mm of involved nail from distal nail groove to proximal limit of disease
Confirmed presence of microorganisms of interest by KOH and qPCR at Screening
The affected treatment-targeted great toenail(s) is capable of re-growth as documented by subject self-reported history of clipping nails at least monthly
You may not be if
Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study
Any dermatological conditions that could interfere with clinical evaluations
Great toenails with only superficial white onychomycosis, any evidence of subungual mycetoma as evidenced by yellow or white spikes, or any evidence of proximal onychomycosis
Any underlying disease(s) or other dermatological condition(s) that requires the use of interfering topical or systemic therapy, with the exception of certain protocol-specified that require a defined washout period for eligibility
Treatment of any type of cancer within the last 6 months, with the exception of superficial skin cancers such as basal cell carcinoma and squamous cell carcinoma
History of any significant internal disease which contraindicates the use of live microbiome
History of failing oral or prescription topical treatment for onychomycosis
A history of current episode of onychomycosis present for more than 3 years
Nail or anatomic abnormalities of the target great toenail(s)
AIDS or AIDS-related complex by medical history
History of current street drug or alcohol abuse, or street drug or alcohol abuse within the past year
Subjects known or suspected to be taking immune suppressive medications or subjects who are immunosuppressed
Subjects with poorly controlled diabetes mellitus requiring medical intervention/treatment
Subjects with peripheral vascular disease based on medical history
Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study
