A Phase 2 interventional study of CELEXT07 and Penlac in Onychomycosis, sponsored by 9305-9954 Quebec Inc. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-26.
Sponsored by 9305-9954 Quebec Inc · Phase 2, Interventional, and Treatment
This will be an interventional safety and efficacy study of CELENT07 when used as a topical treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. This is randomized, double-blind, parallel design, placebo and active controlled study in patients with mild to moderate toenail distal lateral subungual onychomycosis (DLSO) (n=120). Subjects will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or PENLAC®, daily for 52 weeks. Efficacy assessments will include complete cure, mycologic cure and clinical efficacy and safety and tolerability.
153 studies on the registry are indexed under Onychomycosis; 15 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 138 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →9305-9954 Quebec Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Subjects are eligible to be included in the study only if they meet all of the following criteria:
Exclusion Criteria
Subjects will be excluded from the study if they meet any of the following criteria:
suspension that is applied topically to the infected nail(s) daily.
Drug: CELEXT07
placebo is a suspension that simulates the physical properties of the experimental agent CELEXT07. It is applied topically to the infected nail(s) daily.
Other: vehicle solution
Is a standard of care for the condition and is applied topically to the infected nail(s) daily.
Drug: Penlac
Also known as: topical Penlac nail lacquer
Also known as: placebo
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes. and no residual involvement of the target toenail. The complete cure is a composite binary variable defined as "Yes" if: * Mycological cure (negative KOH and negative culture for dermatophytes) and * No residual involvement of the target toenail "No" if otherwise
Time frame: week 52
Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks.
Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and \<= 10% residual involvement of the target toenail.Clinical effectiveness is a composite binary variable defined as "Yes" if * Mycological cure (negative KOH and negative culture for dermatophytes) and ◦= 10% residual involvement of the target toenail "No" if otherwise
Time frame: week 52
Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 52 Weeks.
Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes. Mycological cure is a composite binary variable defined as "Yes"if : * Negative microscopy and * Negative culture for dermatophytes "No" if otherwise.
Time frame: week 52
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: week 52
Plan to share: Undecided
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This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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9305-9954 Quebec Inc