Table 4 Histopathological evaluation criteria a
From: Pirfenidone gel in patients with localized scleroderma: a phase II study
Epidermal atrophy | Dermal infiltration | Adipose tissue infiltration | Papillary dermis fibrosis | Reticular dermis fibrosis | Adipose tissue fibrosis | Adnexal atrophy | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Basal | Final | Basal | Final | Basal | Final | Basal | Final | Basal | Final | Basal b | Final c | Basal | Final | |
Absence | 1 | 4 | 0 | 0 | 4 | 3 | 1 | 3 | 1 | 4 | 2 | 0 | 1 | 1 |
Light | 1 | 4 | 4 | 8 | 3 | 9 | 6 | 3 | 4 | 2 | 3 | 3 | 4 | 3 |
Moderate | 4 | 1 | 5 | 3 | 5 | 0 | 2 | 3 | 1 | 6 | 2 | 1 | 3 | 3 |
Severe | 6 | 3 | 3 | 1 | 0 | 0 | 3 | 3 | 6 | 0 | 4 | 5 | 4 | 5 |
Mean (SD) | 2.25 (0.96) | 1.25 (1.21) | 1.92 (0.79) | 1.42 (0.67) | 1.08 (0.90) | 0.75 (0.45) | 1.58 (1.0) | 1.5 (1.17) | 2 (1.13) | 1.17 (0.94) | 1.72 (1.19) | 2.22 (0.97) | 1.83 (1.03) | 2 (1.04) |
P-valued | 0.010 | 0.034 | 0.305 | 0.705 | 0.039 | 0.276 | 0.581 | |||||||