TABLE 2.
LSM | ED (95% CI) | |||||
---|---|---|---|---|---|---|
Pharmacodynamic parameter | KLH | Placebo | KLH vs placebo | |||
Anti‐KLH antibodies | ||||||
Anti‐KLH IgM (% change) | 1.59 | 1.00 | 37.3% (19.4–51.2%)b | |||
Anti‐KLH IgG (% change) | 3.03 | 0.98 | 67.7% (56.3–76.1%)d |
LSM | ED (95% CI) | |||||
---|---|---|---|---|---|---|
i.m. KLH i.d. KLH (n = 12) | i.m. placebo i.d. KLH (n = 3) | i.m. KLH or placebo i.d. untreated (n = 15) | i.m. KLH i.d. KLH vs | i.m. KLH i.d. KLH vs | i.m. placebo i.d. KLH vs | |
i.m. placebo i.d. KLH | i.m. KLH or placebo i.d. untreated | i.m. KLH or placebo i.d. untreated | ||||
Skin blood perfusion | ||||||
LSCI | ||||||
Basal flow (AU) | 42.89 | 31.97 | 31.14 | 10.92 (1.41–20.44)a | 11.75 (6.59–16.91)c | −0.83 (−9.75–8.10) |
Flare (AU) | 79.57 | 74.72 | 74.84 | 4.86 (1.24–8.48)a | 4.74 (2.59–6.88)c | 0.12 (−3.33–3.58) |
Erythema | ||||||
Multispectral imaging | ||||||
Average redness (AU) | 1.17 | 0.91 | 0.97 | 0.26 (0.05–0.47)a | 0.21 (0.09–0.32)b | 0.05 (−0.14–0.25) |
CIELab a* (AU) | 14.88 | 11.79 | 12.88 | 3.09 (0.84–5.34)b | 2.00 (0.79–3.22)b | 1.09 (−1.04–3.22) |
Colorimetry | ||||||
CIELab a* (AU) | 13.05 | 11.37 | 11.45 | 1.69 (−0.29–3.66) | 1.61 (0.57–2.65)b | 0.08 (−1.72–1.88) |
Erythema index | ||||||
Erythema index (% change) | 62.58 | 61.39 | 57.45 | 1.9% (−13.6 to 15.3%) | 8.2% (1.5 to 14.4%)a | −6.8% (−21.8 to 6.3%) |
Oedema | ||||||
Multispectral imaging | ||||||
Oedema height (mm) | 0.17 | 0.06 | 0.04 | 0.11 (−0.01–0.22) | 0.12 (0.06–0.19)b | −0.02 (−0.13–0.09) |
Oedema area (% change) | 8.28 | 4.15 | 4.74 | 49.9% (−1.85 × 106 to 100%) | 42.8%(−7.00 × 104 to 100%) | 12.4%(−5.32 × 107 to 100%) |
Oedema volume (% change) | 1.45 | 0.41 | 0.88 | 71.4%(−1.46 × 107 to 100%) | 39.2%(−1.68 × 105 to 100%) | 53.0%(−4.47 × 108 to 100%) |