Table 1.
Demographics and results
| Baseline demographics of participants | |||
|
| |||
|---|---|---|---|
| Variable | TA (n=9) | Placebo (n=8) | P |
| Age (year), median (IQR) | 45 [42-51] | 41 [39-48] | 0.27 |
| BMI, median (IQR) | 26 [24-36] | 22 [22-24] | 0.03 |
| Ethnicity | 0.53 | ||
| Aboriginal | 0 (0%) | 1 (12.5%) | |
| African | 1 (11.1%) | 1 (12.5%) | |
| Asian | 3 (33.3%) | 2 (25%) | |
| Caucasian | 5 (55.6%) | 2 (25%) | |
| Mixed | 0 (0%) | 2 (25%) | |
| Skin type | 0.57 | ||
| II | 3 (33.3%) | 2 (25%) | |
| III | 3 (33.3%) | 5 (62.5%) | |
| IV | 3 (33.3%) | 1 (12.5%) | |
| Duration of melasma (years), median (IQR) | 7 [5-10] | 8 [4-16] | 0.96 |
| Melasma severity | |||
|
| |||
| Results | |||
|
| |||
| Baseline | 12 weeks | 24 weeks | |
|
| |||
| mMASI: Intention-to-treat analysisa | |||
|
| |||
| TA (n=9) | 13.06±5.19 | 5.13±5.32 | 4.80±3.42 |
| Placebo (n=8) | 12.21±4.32 | 7.75±5.64 | 7.78±6.05 |
| Difference from baseline TA | 7.92±1.93 (-60.7%) |
8.26±2.68 (-63.2%) |
|
| Difference from baseline placebo | 4.46±3.26 (-36.5%) |
4.44±3.61 (-36.3%) |
|
| Between group difference, P value | 0.72 | 0.016 | 0.025 |
|
| |||
| mMASI: Per-protocol analysisb | |||
|
| |||
| TA (n=7) | 12.81±5.53 | 5.27±5.74 | 4.84±3.30 |
| Placebo (n=7) | 11.37±3.89 | 6.27±4.09 | 6.30±4.73 |
| Difference from baseline TA | 7.54±2.05 (-58.9%) |
7.97±3.02 (-62.2%) |
|
| Difference from baseline placebo | 5.10±2.93 (-44.9%) |
5.07±3.39 (-44.6%) |
|
| Between group difference, P value | 0.58 | 0.096 | 0.12 |
|
| |||
| Melanin Index: Intention-to-treat analysis | |||
|
| |||
| TA (n=9) | 106.63±103.12 | 74.26±71.58 | 80.19±103.45 |
| Placebo (n=8) | 90.25±70.16 | 63.42±80.38 | 96.75±76.24 |
| Difference from baseline TA | 32.37±54.02 (-30.4%) |
26.44±37.72 (-24.8%) |
|
| Difference from baseline placebo | 26.83±33.59 (-29.7%) |
-6.50±34.52 (+7.2%) |
|
| Between group difference, P value | 0.71 | 0.81 | 0.081 |
|
| |||
| Melanin Index: Per-protocol analysis | |||
|
| |||
| TA (n=7) | 107.43±109.03 | 75.67±60.34 | 83.29±105.07 |
| Placebo (n=7) | 86.33±74.83 | 55.67±83.53 | 93.76±81.85 |
| Difference from baseline TA | 31.76±61.77 (-29.6%) |
24.14±42.38 (-22.5%) |
|
| Difference from baseline placebo | 30.67±34.34 (-35.5%) |
-7.43±37.18 (+8.6%) |
|
| Between group difference, P value | 0.68 | 0.97 | 0.16 |
|
| |||
| Quality of life: Intention-to-treat analysis | |||
|
| |||
| TA (n=9) | 43.89±11.61 | 25.89±15.45 | 39.11±17.80 |
| Placebo (n=8) | 44.38±18.08 | 33.13±21.98 | 38.13±21.81 |
| Difference from baseline TA | 18.00±18.36 (-41.0%) |
4.78±14.91 (-10.9%) |
|
| Difference from baseline placebo | 11.25±16.29 (-25.3%) |
6.25±9.13 (-14.1%) |
|
| Between group difference, P value | 0.95 | 0.44 | 0.81 |
|
| |||
| Quality of life: Per-protocol analysis | |||
|
| |||
| TA (n=7) | 43.71±12.68 | 24.14±15.39 | 41.14±18.32 |
| Placebo (n=7) | 40.71±16.01 | 27.86±17.45 | 33.57±19.02 |
| Difference from baseline TA | 19.57±20.55 (-44.8%) |
2.57±16.03 (-5.9%) |
|
| Difference from baseline placebo | 12.86±16.90 (-31.6%) |
7.14±9.48 (-17.5%) |
|
| Between group difference, P value | 0.70 | 0.52 | 0.53 |
TA=Tranexamic, IQR=Inter-quartile range *All results reported as mean and standard deviation unless specified. aIntention-to-treat analysis: all participants who were randomised were included. bPer-protocol analysis: participants did not adhere to the study protocol were excluded