A double-blind, randomized controlled trial on the efficacy and safety of 4% niacinamide cream on the treatment of mild to moderate chronic plaque psoriasis at the University of Santo Tomas Hospital Out-Patient Department

ABSTRACT

@#Background: Niacinamide is known for its anti-inflammatory effect and skin penetration capability. Currently, limited studies are available on its efficacy on psoriasis. Objective: This study aimed to determine the efficacy and safety of 4% niacinamide cream on mild to moderate psoriasis. Methods: 40 patients were randomly allocated to 4% niacinamide cream (N), or 0.1% triamcinolone acetonide cream (TAC) or 4% niacinamide cream and 0.1% triamcinolone acetonide cream (N-TAC) for 10 weeks treatment. A 50% improvement in psoriasis area severity index (PASI50) was considered as the primary endpoint of the study. Secondary outcome measures were physician global assessment (PGA), dermatology life quality index (DLQI), and adverse events. PASI and PGA were assessed biweekly. DLQI was assessed at the start and at the end of the study period. Results: PASI50 was achieved in 85% of patients in N-TAC, 75% of patients in TAC and 15% of patients in N. There was no statistical significant difference between groups TAC and N-TAC (p=0.645, Fisher’s exact test). A higher number of patients in N-TAC (31%) achieved PGA1 score or “almost clear” and reached PASI50 earlier (60% at week 4). A higher improvement in DLQI score was seen in N-TAC; however, mean DLQI improvement did not vary by treatment group (p=0.0770). No adverse event was reported for groups TAC and N-TAC while pruritus and erythema were noted in N. Conclusion: Monotherapy of 4% niacinamide cream was not effective in the treatment of mild to moderate psoriasis. The combination N-TAC showed a continuous and sustained improvement of lesions compared to monotherapy TAC.