Al-Azhar Med. J.( Medicine). Vol. 50(2), April, 2021, 1415 - 1424 DOI: 10.12816/amj.2021.158621 https://amj.journals.ekb.eg/article_158621.html EVALUATION OF EFFICACY AND SAFETY OF TOPICAL NICOTINAMIDE FOR TREATMENT OF PSORIASIS VERSUS CALCIPOTRIOL- BETAMETHASONE: COMPARATIVE STUDY By Ahmed Saeed Mostafa Anbar, Mohammed Ahmed El-Khalawany and Ahmed Hassan Nouh Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Al-Azhar University Corresponding Author: Ahmed Saeed Mostafa Anbar, Mobile: +201024274795, E-mail: [email protected] ABSTRACT Background: Psoriasis is a chronic skin disorder typically characterized by symmetrical erythematous papules and plaques with a silver scale. Objective: To compare the efficacy and safety of topical nicotinamide for the treatment of mild to moderate psoriasis in Interventional Clinical Trial study compared with calcipotriol-betamethasone. Patients and methods: Our study was carried out on sixty patients from November 2019 to March 2020, complaining of psoriasis thirty patients treated by topical nicotinamide 4% weekly and thirty patients treated by topical calcipotriol-betamethasone weekly. Patients were selected from out-patient clinic of Dermatology, Venereology and Andrology Department of Al-Azhar University Hospitals. Results: The present study using topical nicotinamide 4% weekly versus calcipotriol –betamethasone weekly showed lesions on both sides were similar regarding baseline Psoriasis Area and Severity Index (PASI) score (P = 0.148), while at 1 month and 3 months after therapy, PASI scores were significantly lower with calcipotriol betamethasone in the second group as compared with nicotinamide alone in first group (P < 0.001). At the end of the trial, PASI scores were reduced by 17.9± 7.8 points before treatment to 12.2± 5.08 after 12 weeks with nicotinamide as compared to 16.2 ± 5.5 before treatment to 9.1± 3.2 points with calcipotriol betamethasone (P < 0.001). Conclusion: Nicotinamide can be used for topical psoriasis treatment and may be a good adjuvant to be added to the treatment regimens of psoriasis and it was less effective than calcipotriol betamethasone regarding clinical response and patient's satisfaction. Keywords: Nicotinamide 4%, Calcipotriol-betamethasone, Psoriasis. INTRODUCTION The scalp, tips of fingers and toes, Psoriasis is a chronic proliferative and palms of the hands, soles of the feet, under inflammatory condition of the skin. It is the breasts and genital areas, elbows, characterized by erythematous plaques knees and lower back are most commonly covered with silvery scales particularly affected sites (Kuchekar et al., 2011). over the extensor surfaces, scalp, and lumbosacral region (Elman et al., 2018). 1415 1416 AHMED SAEED MOSTAFA ANBAR et al., Clinical presentation is widely inhibiting the nuclear poly (ADP-ribose) variable; some patients may have minimal polymerase-1 (PARP-1). Niacinamide is a plaques confined to a small amount of well-tolerated and safe substance often skin surface area and others may have used in cosmetics (Rovito and Oblong, nearly the entire cutaneous surface 2013). covered with psoriatic lesions (Nguyen et Nicotinamide is an inhibitor of poly al., 2019). (ADP-ribose) polymerase-1 (PARP-1) The cause of psoriasis is not fully that, through enhancement of nuclear understood, but it is believed to have a kappa B-mediated transcription, plays a genetic component and local psoriatic pivotal role in the expression of changes can be triggered by multiple inflammatory cytokines, chemokines, factors that cause insult to the skin (Parisi adhesion molecules, and inflammatory et al., 2013). mediators (Drago et al., 2016). Various environmental factors have Through interaction with CD38 and been suggested as aggravating to inhibition of IL-1, IL-12, and TNF-alpha psoriasis, including stress, Certain drugs production, nicotinamide produces a mild like chloroquine, lithium, beta-blockers, TH2 bias. Nicotinamide is a potent steroids, and NSAIDs can worsen phosphodiesterase inhibitor and psoriasis. Generally, summer improves suppresses neutrophil chemotaxis and psoriasis while winter aggravates it. Apart mast cell histamine release. It inhibits from above factors infections, nitric oxide synthase mRNA induction psychological stress, alcohol, smoking, and suppresses antigen-induced obesity, and hypocalcemia are other lymphocyte transformation (Park et al., triggering factors for psoriasis (Nguyen et 2010). Nicotinamide increases the al., 2019). biosynthesis of ceramides, which upon Nicotinamide (niacinamide) is the degradation produce sphingosine. water-soluble, amide isotype of vitamin Sphingosine inhibits protein kinase C B3; niacin (nicotinic acid) is the (PKC) and decreases basal cell corresponding acid isotype. Niacinamide proliferation dependent on PKC an amide of vitamin B3 (niacin) is a (Morganti et al., 2011). hydrophilic endogenous substance. Its Current treatment strategies of effects after epicutaneous application have psoriasis are not completely satisfactorily. long been described in the literature (Chen By inhibiting inflammatory cytokines, and Damian, 2014). nicotinamide may enhance the effects of Given a sufficient bioavailability, current topical treatments. Preliminary niacinamide has antipruritic, studies have shown that nicotinamide, antimicrobial, vasoactive, photo- which is a vitamin B derivative, is protective, sebostatic and lightening effective in the treatment of psoriasis effects depending on its concentration. (Levine et al., 2010). Within a complex metabolic system The aim of this work was to compare niacinamide controls the NFκB-mediated the efficacy and safety of topical transcription of signalling molecules by nicotinamide 4% versus calcipotriol- 1417 EVALUATION OF EFFICACY AND SAFETY OF TOPICAL… betamethasone in the treatment of The patients were divided into two psoriasis. equal groups (30) patients in each group. Group I was treated with nicotinamide PATIENTS AND METHODS (4%) and Group II with calcipotriol twice This study was carried out on a total of daily for 12 weeks. After the first, second 60 patients with psoriasis from November and third months of therapy, psoriasis 2019 to March 2020. The patients were severity was evaluated using the modified diagnosed by typical clinical and psoriasis area and severity index (PASI). dermoscopic findings. The patients were Patient's satisfaction was evaluated at the able to read and give consents. Patients end of the trial using a 10-point rating were selected from out-patient clinic of scale according to dermatology life Dermatology, Venereology and quality index (DLQI). Serial photographs Andrology Department of Al-Azhar and dermoscopic examination every University Hospitals. month were followed for all patients. All patients were subjected to complete Devices used were: medical history, dermatological 1. Dermoscope Gen Derma Light 4. examination and documented digital photography. 2. Nikon D5300 with Nikkor lens (18- 55nm. Exclusion criteria: Statistical analysis: 1. Age below 18 years. Results of the present study were 2. Those that used any medication or statistically analyzed using SPSS 25 niacin and multi-vitamins two weeks, (IBM, USA). Data were represented as or anti-psoriatic systemic drugs or beta- median, mean and SD or number and blockers one month prior to the study percentage. Numerical data were 3. Patients who>15% of body surface compared using Mann- Whitney U test area. while categorical data were compared using Fisher exact test or Chi-square test 4. Pregnant women. as appropriate. ROC curve was used to 5. Those with the history of renal, evaluate the performance of different tests hematologic, liver and major differentiate between certain groups. P psychiatric diseases. value < 0.050 was considered significant. 6. Those with only nail, flexural, palmoplantar, or pustular psoriasis. 1418 AHMED SAEED MOSTAFA ANBAR et al., RESULTS The present study included 60 psoriatic Thus, a total number of 60 patients (16 patients divided into two groups. males), (14 females) in the first group and Regarding demographic data, there was (17males), (13females) in the second no statistically significant difference group with mean age of 36.5 ± 8.5 (22-56) between both groups regarding age, sex, years completed the trial. The PASI score duration of lesions and previous of each side of the cases at three treatments. measurements were recorded. Analyses The patients group included 16males showed that lesions on both sides were (53%) and 14 females (43%). Their ages similar regarding baseline PASI score (P = range from 18 to 66 years (Mean age ±SD 0.148), while at 1 month and 3 months 41.9 ± 16.01). Duration of the disease after therapy, PASI scores were ranged from 1 year to 17 years (Mean significantly lower with calcipotriol ±SD 8.7 ± 6.5). betamethasone in group one as compared As regard the severity of psoriasis, with nicotinamide alone (P < 0.001). At PASI score ranged from 3.6 to 42.5 (Mean the end of the trial, PASI scores were ±SD 11.1 ± 7.7). reduced by 17.9± 7.8 points before During the study period, we evaluated treatment to 12.2± 5.08 after 12 weeks 60 patients divided into two groups, from with nicotinamide as compared to 16.2 ± which 7 patients did not match the 5.5 before treatment to 9.1± 3.2 points inclusion criteria and 4 were not willing to with calcipotriol-betamethasone (P < participate. Also, during the study period, 0.001- Table 1). 5 patients in first group treated with There was no statistically significant nicotinamide