ABSTRACT
The objective of this study is to test the efficacy and safety of Plai gel containing 1% Plai oil in treatment of mild to moderate acne vulgaris. Randomized, double blinded, placebo controlled trial was conducted in 60 healthy volunteers. The primary outcome is expressed in percentage reduction in total acne lesions (inflammatory lesions and non inflammatory lesions). Assessments were performed at week 2, 4, and 8. A percentage reduction in total acne lesions in plai group was higher than the placebo group at week 2 [6 times (95%CI: -16 to 28)] and week 4 [12 times (95%CI: -12 to 35)]. A percentage reduction in noninflammatory acne lesions in plai group was higher than the placebo group at week 2 [14 times (95%CI: -17 to 43)] and week 4 [26 times (95%CI: -4 to 64)]. However, such differences did not show statistical significance. At week 8, there were no differences between two groups. The plai group showed a significant reduction of noninflammatory acne lesions from the baseline at week 2 (45 ± 29 lesions) and week 4 (41 ± 25 lesions), while the placebo did not so. A percentage reduction in inflammatory acne lesions in plai group was lower than the placebo group at week 2 [2.9 (95%CI:-37.6 to 31.8)] and week 4 [12.1 (95%CI:-42.2 to 17.9), however, there were no significant differences. For the secondary outcome, success rate at week 8 was 39% in plai group and 31% in placebo group. However, this difference did not show statistical significance. Plai gel was safe. Adverse events were not found in this study. The compliance to use plai gel was greater than 90%. In conclusion, plai gel is promising to be used in treatment of mild to moderate acne, which the effect could be seen within the first month as compared to placebo.