Table 1 Benchmark for secondary efficacy endpoints
A. Tinea lesions scoring19 | ||
Score | Description | |
0 | Absent | |
1 | Mild | |
2 | Moderate | |
3 | Severe | |
4 | Very severe | |
B. Scoring Clinical Index for Onychomycosis (SCIO)18 | ||
Score | Grade | Description |
0 | None | • No infection |
1 | Mild | • Depth of involvement <1/3 • Scaling/ hyperkeratosis absent or <1 mm • Discolouration of nail |
2 | Moderate | • Depth of involvement 1/3 to 2/3 • Scaling/ hyperkeratosis 1–2 mm • Acute Paronychia [acute inflammation surrounding nail(s)] • Nail plate dystrophy up to 50%. |
3 | Severe | • Depth of involvement >2/3 • Scaling/ hyperkeratosis >2 mm • Chronic Paronychia [chronic inflammation surrounding nail(s)] • Nail plate dystrophy >50% |
C. Investigator Global Assessment (IGA) response20 | ||
Score | Response | Description |
5 | Cleared | 100% remission except residual manifestations |
4 | Excellent | 90–99% improvement |
3 | Good | 50–89% improvement |
2 | Fair | 25–49% improvement |
1 | Poor | <24% improvement |
0 | Worse | deterioration from baseline |