TABLE 3.
Summary of clinical trials supporting the application of IN.
| Disease | Study design/sample size | Treatment | Outcomes | Reference |
|---|---|---|---|---|
| UC | Placebo-controlled RCT/86 | 0.5 g IN, once daily, orally for 8 weeks | The rate of clinical response: 69.6% (0.5 g IN), 13.6% (placebo) | Naganuma et al. (2018) |
| 1 g IN, once daily, orally for 8 weeks | The rate of clinical response: 75% (1.0 g IN), 13.6% (placebo) | |||
| 2 g IN, once daily, orally for 8 weeks | The rate of clinical response: 81% (2.0 g IN), 13.6% (placebo) | |||
| 0.5 IN, once daily, orally for 8 weeks | The rate of clinical remission: 26.1% (0.5 g IN), 4.5% (placebo) | |||
| 1 g IN, once daily, orally for 8 weeks | The rate of clinical remission: 55% (1.0 g IN) vs. 4.5% (placebo) | |||
| 2 g IN, once daily, orally for 8 weeks | The rate of clinical remission: 38.1% (2.0 g IN) vs. 4.5% (placebo) | |||
| 0.5 IN, once daily, orally for 8 weeks | The rate of mucosal healing: 56.5% (0.5 g IN), 13.6% (placebo) | |||
| 1 g IN, once daily, orally for 8 weeks | The rate of mucosal healing: 60% (1.0 g IN), 13.6% (placebo) | |||
| 2 g IN, once daily, orally for 8 weeks | The rate of mucosal healing: 47.6% (2.0 g IN), 13.6% (placebo) | |||
| UC | Open-label, prospective pilot/20 | 2 g IN, once daily, orally for 8 weeks | The rate of clinical response: 72% | Sugimoto et al. (2016) |
| 2 g IN, once daily, orally for 8 weeks | The rate of clinical remission: 33% | |||
| 2 g IN, once daily, orally for 8 weeks | The rate of mucosal healing: 61% | |||
| Psoriasis | Randomized, observer-blind, vehicle controlled trial/42 | IN ointment, once daily, topically for 12 weeks | The sum of scaling, erythema, and induration scores: 6.3 (IN ointment), 12.8(vehicle ointment). Plaque area percentage: 38.5% (IN ointment), 90% (vehicle ointment) | Lin et al. (2008) |
| Psoriasis | Noncontrolled pilot Study/28 | IN ointment, twice daily, topically for 24 weeks | The Nail Psoriasis Severity Index: 14.9 ± 11.1 (at week 24), 36.1 ± 14.7 (at baseline) | Lin et al. (2011) |
| Psoriasis | Randomized, observer-blind, vehicle-controlled trial/31 | IN ointment, twice daily, topically for 24 weeks | The reduction of Nail Psoriasis Severity Index: 49.8% (Lindioil group), 22.9% (control group) | Lin et al. (2014) |
| Psoriasis | Randomized, double-blind, dosage-controlled trial/98 | 0.5 g IN ointment (200 μg/g of indirubin)/100 cm2 of psoriatic lesion area, twice daily, topically for 8 weeks | The reduction of Psoriasis Area and Severity Index: 69.2%, the proportion of subjects achieving 75 and 90% reductions in PASI scores 56·5% and 30·4% | Lin et al. (2018) |
| 0.5 g IN ointment (100 μg/g of indirubin)/100 cm2 of psoriatic lesion area, twice daily, topically for 8 weeks | The reduction of Psoriasis Area and Severity Index: 63.1%, the proportion of subjects achieving 75 and 90% reductions in PASI scores 44 and 8% | |||
| 0.5 g IN ointment (50 μg/g of indirubin)/100 cm2 of psoriatic lesion area, twice daily, topically for 8 weeks | The reduction of Psoriasis Area and Severity Index: 50.3%, the proportion of subjects achieving 75 and 90% reductions in PASI scores 24 and 4% | |||
| 0.5 g IN ointment (10 μg/g of indirubin)/100 cm2 of psoriatic lesion area, twice daily, topically for 8 weeks | The reduction of Psoriasis Area and Severity Index: 53.4%, the proportion of subjects achieving 75 and 90% reductions in PASI scores 24 and 4% |