Pirfenidone gel in patients with localized scleroderma: a phase II study

Table 3 Effectiveness clinical variables ^a

Patient	Initial mLoSSI	Final mLoSSI	Improvement mLoSSI (%)	Mean basal durometer	Mean final durometer	Improvement durometer (%)	Initial VAS hardness	Final VAS hardness	Improvement VAS hardness (%)	Initial VAS pruritus	Final VAS pruritus	Improvement VAS pruritus (%)
1	1	0	100	56.73	49.12	13.41	0	4	−4	0	5	−5
2	3	0	100	35.6	34.51	3.06	0	0	0	0	0	0
3	14	6	57	36.95	38.09	−3.08	7	5	29	0	0	0
4	11	1	93	28.37	30.27	−6.7	8	2	75	7	2.5	65
5	9	0	100	33.71	31.14	7.62	5	3	40	8	3	62
6	3	0	100	26.21	27.03	−3.13	6.5	1.5	77	6.5	2	69
7	2	0	100	32.49	35.39	−8.93	10	4.5	55	5	2.5	50
8	2	1	50	30.23	26.26	13.13	5	3	40	0	0	0
9	4	2	50	45.52	42.02	7.69	7	3	57	5	2	60
10	3	0	100	42.68	35.29	17.31	8	0	100	5	0	100
11	14	0	100	36.83	27.05	26.56	0	0	0	3	0	100
12	4	0	100	24.18	13.51	44.12	3	3	0	8	0	100
Mean	5.83	0.83	NA	35.79	32.47	NA	4.96	2.42	NA	3.96	1.42	NA
P-value^b		0.002			0.05			0.032			0.065

^aThe response to pirfenidone is evidenced by improvement in both physician (mLoSSI and durometer units) and patient (hardness of the lesions) evaluations. ^bWilcoxon rank-sum test. mLoSSI, Modified Localized Scleroderma Skin Severity Index; VAS, Visual analogue scale.

ISSN: 1478-6362