- Primary efficacy endpoint: Clinical cure: Resolution of all signs and symptoms (all scores = 0) without further antifungal treatment at Test-of-Cure (TOC) visit (Day 10)
- Secondary efficacy parameters:
- Clinical outcome at Follow-Up (FU) visit (Day 25)
- Mycological eradication (negative culture) at Days 10 and 25
- Use of antifungal rescue therapy and changes from baseline signs and symptoms score also evaluated
- Signs and symptoms:
- By investigator: Edema (swelling of tissue), Erythema (redness), Excoriation (fissures)
- By patient: Burning, Itching, Irritation
- Scoring scale: 0 (absent), 1 (mild), 2 (moderate), 3 (severe)
- Score range on scale: 0-18
Results based on mITT population | * No rescue antifungal use.
Signs and Symptoms [S&S] score defined as a composite endpoint of the subject’s reported symptoms (burning, itching and irritation) and the investigator’s assessed signs (swelling, redness and excoriations). Each sign and symptom can be absent, mild, moderate or severe, with a corresponding score from 0 to 3. The total composite scale goes from 0 to 18 points.
Results based on mITT population.
Mean signs and symptoms score based on 0-18 scale.
P value based on change from baseline score mean difference between SCY-078 600mg and FLU.