Table 2 a and b: Effects of Botulinum toxin type A on the 30 patients enrolled in the study (2a), with details given separately for HHD and DD (2b)

Dropped-out patients—n (%)

9 (30)

9 (30)

11 (36.7)

Relapsing patients between [study period]: n (%)

[M0–M1]: 9 (30)

[M1–M3]: 0 (0)

[M3–M6]: 2 (6.7)

Ongoing patients—n (%)

21 (70)

21 (70)

19 (63.3)

Improvement Global Assessment (IGA)—n (%)

IGA0

1 (3.3)

2 (6.7)

4 (13.3)

IGA1

3 (10)

1 (3.3)

2 (6.7)

IGA2

2 (6.7)

4 (13.3)

0 (0)

IGA3

9 (30)

7 (23.3)

6 (20)

IGA4

6 (20)

7 (23.3)

7 (23.3)

Effectiveness parameters—mean score (± SD) & p value^a

Disease severity

Total surface area (cm²)

161.5 (± 310.2)

p = 0.0002

106.2 (± 162.9)

p < 0.0001

71.4 (± 126.6)

p < 0.0001

Global severity (score/4)

2.17 (± 1.14)

p = 0.004

2.20 (± 1.24)

p = 0.10

1.99 (± 1.09)

p = 0.02

Quality of life and psycho-social impairment

DLQI (score/30)

8.73 (± 9.48)

p = 0.006

5.14 (± 6.27)

p < 0.0001

4.5 (± 5.93)

p = 0.0001

HidroQoL (score/36)

12.47 (± 10.77)

p = 0.001

8.23 (± 8.55)

p < 0.0001

8.42 (± 6.77)

p = 0.0008

Functional symptoms

Itchiness (VAS/10)

1.96 (± 2.82)

p = 0.0002

1.82 (± 2.31)

p = 0.003

1.61 (± 2.4)

p = 0.001

Cutaneous pain (VAS/10)

1.82 (± 2.41)

p < 0.0001

1.64 (± 2.32)

p = 0.0004

1.85 (± 2.8)

p = 0.001

Sweating (VAS/10)

1.92 (± 2.1)

p < 0.0001

2.38 (± 2.33)

p = 0.0006

2.92 (± 2.05)

p = 0.0005

Odour (VAS/10)

1.2 (± 2.21)

p < 0.0001

1.89 (± 2.54)

p = 0.002

1.97 (± 3.27)

p = 0.005

Skin infections during the 6 months following the injections

Number of skin infections episodes (n)

_

_

_

_

0.37 (± 1.21)

p = 0.002

Dropped-out patients—n (%)

9 (30)

9 (30)

11 (37)

0 (0)

0 (0)

0 (0)

Relapsing patients between [study period]: n (%)

[M0–M1]: 9 (30)

[M1–M3]: 0 (0)

[M3–M6]: 2 (6.7)

[M0–M1]: 0 (0)

[M1–M3]: 0 (0)

[M3–M6]: 0 (0)

Ongoing patients—n (%)

17 (57)

17 (57)

15 (50)

4 (13.3)

4 (13.3)

4 (13.3)

Improvement Global Assessment (IGA)—n (%)

IGA0

1 (3.3)

1 (3.3)

3 (10)

0 (0)

1 (3.3)

1 (3.3)

IGA1

0 (0)

0 (0)

1 (3.3)

3 (10)

1 (3.3)

1 (3.3)

IGA2

2 (6.7)

3 (10.1)

0 (0)

0 (0)

1 (3.3)

0 (0)

IGA3

8 (26.8)

6 (20.1)

5 (16.7)

1 (3.3)

1 (3.3)

1 (3.3)

IGA4

6 (20.1)

7 (23.5)

6 (20)

0 (0)

0 n

1 (3.3)

Effectiveness parameters—mean score (+ SD) & p value^a

Disease severity

Total surface area (cm²)

143.4 (± 321.9)

72.7 (± 136.4)

40.7 (± 53.6)

279.5 (± 212.9)

256.9 (± 208.3)

186.5 (± 245.6)

(p value)

(p < 0.0001)

(p < 0.0001)

(p = 0.0003)

Global severity (score/4)

2.28 (± 1.13)

2.38 (± 1.19)

2.08 (± 1.14)

1.5 (± 1.14)

1.38 (± 1.25)

1.67 (± 0.91)

(p value)

(p = 0.14)

(p = 0.06)

(p = 0.37)

Quality of life and psycho-social impairment:

DLQI (score/30)

8.69 (± 9.73)

4.33 (± 5.4)

4.19 (+ 4.82)

9 (± 8.91)

8.75 (± 9.39)

5.75 (± 10.21)

(p value)

(P = 0.009)

(p < 0.0001)

(p = 0.0003)

HidroQoL (score/36)

12.46 (± 10.71)

7.44 (± 7.86)

9.06 (± 7.03)

12.5 (± 12.87)

11.75 (± 11.87)

5 (± 4.58)

(p value)

(p = 0.003)

(p < 0.0001)

(p = 0.003)

Functional symptoms

Itchiness (VAS/10)

1.82 (± 2.87)

1.44 (± 2.16)

1.5 (± 2.58)

2.8 (± 2.67)

3.5 (± 2.52)

2.05 (± 1.67)

(p value)

(p = 0.002)

(p = 0.008)

(p = 0.01)

Cutaneous pain (VAS/10)

1.87 (± 2.51)

1.56 (± 2.39)

1.81 (± 2.88)

1.5 (± 1.91)

2 (± 2.31)

1.98 (± 2.88)

(p value)

(p < 0.0001)

(p = 0.0009)

(p = 0.001)

Sweating (VAS/10)

1.75 (± 1.92)

2.18 (± 1.94)

2.56 (± 1.86)

3 (± 3.16)

3.25 (± 3.95)

4.35 (± 2.4)

(p value)

(p < 0.0001)

(p = 0.005)

(p = 0.003)

Odour (VAS/10)

1.15 (± 2.29)

1.53 (± 2.45)

1.59 (± 3.14)

1.5 (± 1.91)

3.5 (± 2.55)

3.45 (± 3.87)

(p value)

(p < 0.0001)

(p = 0.01)

(p = 0.03)

Skin infections during the 6 months following the injections

Number of skin infections episodes (n)

_

_

0.33 (± 1.29)

_

0.5 (± 1)

(p value)

(p = 0.01)