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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)

From: Botulinum toxin injections as an effective treatment for patients with intertriginous Hailey-Hailey or Darier disease: an open-label 6-month pilot interventional study

  M1 M3 M6
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 valuea
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
  HHD DD
  M1 M3 M6 M1 M3 M6
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 valuea
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)   
  1. aWilcoxon test for paired values (comparison between each evaluation points versus baseline); p value considered statistically significant when < 0.05 (bold print)
  2. Legend: DLQI: Dermatology Life Quality Index; HidroQoL: Hyperhidrosis Quality of Life Index; IGA: Investigator Global Assessment; M1: 1st month after BtxA injections; M3: 3rd month after BtxA injections, M6: 6th month after BtxA injections; n: number of patients; %: percentage; SD: Standard deviation; VAS: Visual Analogue Scale