Table 1.
CHARACTERISTICS OF PATIENTS WITH SYSTEMIC SCLEROSIS SKIN ULCERS AND THEIR RESPONSE TO CBD COMPARED WITH A CONTROL GROUP
| Characteristics | CBD Group | Control Group |
|---|---|---|
| Patients | ||
| Sex, n (%) | ||
| Female | 22 (88) | 18 (90) |
| Male | 3 (12) | 2 (10) |
| Age, mean (SD), y | 53.0 (14.6) | 57.3 (13.2) |
| Disease duration, mean (SD), y | 10.6 (5.2) | 14.3 (8.6) |
| Cutaneous subset, n | ||
| Limited | 18 | 17 |
| Diffuse | 7 | 3 |
| Treatment, n (%) | ||
| Systemic standard therapies | 25 (100) | 20 (100) |
| Local standard therapies | 25 (100) | 20 (100) |
| Local CBD treatments | 25 (100) | 0 (0) |
| CBD oral administration oil | 25 (100) | 0 (0) |
| Pain VAS (0–100), mean (SD) | ||
| Baseline | 8.40 (0.8) | 8.44 (0.77) |
| End of follow-up (T1)a | 6.00 (0.82) | 7.88 (0.73) |
| Hours of sleep, mean (SD) | ||
| Baseline | 2.56 (1.28) | 2.65 (1.16) |
| End of follow-up (T1)a | 5.67 (0.85) | 3.25 (1.34) |
| HAQ-DI (0–;3), mean (SD) | ||
| Baseline | 2.19 (0.67) | 2.24 (0.26) |
| End of follow-up (T1) | 1.61 (0.41) | 2.19 (0.62) |
| Additional analgesic therapy, n (%) | ||
| Baseline | ||
| End of follow-up (T1) | 12 (48) | 20 (100) |
| Skin ulcer evolution, n (%) | ||
| Healing | 18 (72) | 6 (30) |
| Adherence to CBD protocol, n (%) | 25 (100) | N/A |
| Local adverse effects of CBD, n (%) | ||
| Severe adverse events | 0 (0) | N/A |
| Mild adverse effects (itch, perilesional erythema) | 7 (28) | N/A |
aP = .0001
Abbreviations: CBD, cannabidiol; HAQ-DI, Health Assessment Questionnaire Disability Index; N/A, not applicable; VAS, visual analog scale.