Pilot, multicenter, double-blind, randomized placebo-controlled bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis

Levine, Danielle; Even‐Chen, Zeev; Lipets, Irina; Pritulo, O. A.; Sviatenko, Tetiana; Andrashko, Yuri; Lebwohl, Mark; Gottlieb, Alice B.

doi:10.1016/j.jaad.2009.10.016

Cited by 35 publications

(32 citation statements)

References 7 publications

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“…Study data regarding anti-inflammatory effects exist for atopic dermatitis [59,60], psoriasis [59,61,62], rosacea [63,64] and acne vulgaris [65,66]. However, the design and clinical end points of these studies are not appropriate to prove the clinical effectiveness of the respective preparations; they are pilot studies.…”

Section: Clinical Efficacy After Topical Applicationmentioning

confidence: 99%

Niacinamide - Mechanisms of Action and Its Topical Use in Dermatology

Wohlrab¹,

Kreft²

2014

Skin Pharmacol Physiol

102

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Niacinamide, an amide of vitamin B₃ (niacin), is a hydrophilic endogenous substance. Its effects after epicutaneous application have long been described in the literature. Given a sufficient bioavailability, niacinamide has antipruritic, antimicrobial, vasoactive, photo-protective, sebostatic and lightening effects depending on its concentration. Within a complex metabolic system niacinamide controls the NFκB-mediated transcription of signalling molecules by inhibiting the nuclear poly (ADP-ribose) polymerase-1 (PARP-1). Niacinamide is a well-tolerated and safe substance often used in cosmetics. Clinical data for its therapeutic use in various dermatoses can increasingly be found in the literature. Although the existing data are not sufficient for a scientifically founded evaluation, it can be stated that the use of niacinamide in galenic preparations for epicutaneous application offers most interesting prospects.

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Section: Clinical Efficacy After Topical Applicationmentioning

confidence: 99%

Niacinamide - Mechanisms of Action and Its Topical Use in Dermatology

Wohlrab¹,

Kreft²

2014

Skin Pharmacol Physiol

102

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“…In a pilot study by Levine et al ., on patients with moderate psoriasis, the effect of calcipotriol alone or with various doses of nicotinamide was evaluated. This study found that the combination regime of 0.005% calcipotriene and 1.4% nicotinamide was effective in the treatment of psoriasis;[5] however, the study sample size limited the results to show statistically significant differences. Hence, the goal of the current study was to investigate the beneficial effects of adding nicotinamide to calcipotriol for patients with mild to moderate psoriasis.…”

Section: Introductionmentioning

confidence: 99%

Topical nicotinamide in combination with calcipotriol for the treatment of mild to moderate psoriasis: A double-blind, randomized, comparative study

et al. 2013

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Background:Current treatment strategies of psoriasis are not completely satisfactorily. By inhibiting inflammatory cytokines, nicotinamide may enhance the effects of current topical treatments. We investigated whether the combination of topical calcipotriol and nicotinamide is more effective than calcipotriol alone in treatment of psoriasis.Materials and Methods:Adult patients with mild to moderate psoriasis were randomized to receive topical calcipotriol 0.005% and nicotinamide 4% in combination or calcipotriol 0.005% alone, twice daily for 12 weeks. Patients were visited by a dermatologist at baseline and then after the first and third month of therapy, and psoriasis severity was evaluated using the modified psoriasis area and severity index (PASI). Also, patient's satisfaction was evaluated at the end of the trial using a 10-point rating scale.Results:Sixty-five patients (35 males, mean age = 36.5 ± 8.5 years) completed the trial. Lesions on both sides were similar regarding baseline PASI score. At the end of the trial, PASI score was more reduced with calcipotriol+nicotinamide compared to calcipotriol alone (83.6 ± 7.9% vs. 77.8 ± 9.7%, P < 0.001). Patients were also more satisfied with the improvement of lesions with calcipotriol+nicotinamide compared with calcipotriol alone (P < 0.001). Side effects included mild erythema and pruritus (4.6%) and moderate burning and sensitivity to light (3.0%).Conclusions:Nicotinamide can enhance the efficacy of calcipotriol when used in combination for topical psoriasis treatment, and it may be a good adjuvant to the current treatment regimens of psoriasis.

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“…Calcipotriene is inactivated by UVA and therefore should not be applied before treatments. A pilot study recently explored whether combination calcipotriene and nicotinamide was more effective than either agent alone [40]. Despite small patient numbers, data showed that 50% of patients in the combination group achieved clear to almost-clear status at week 12 as compared with 18.8% of placebo (p = 0.002), 25% of nictotinamide monotherapy (p = 0.02), and 31.5% of calcipotriene monotherapy patients (p = 0.096) [40].…”

Section: Vitamin D3 Analogsmentioning

confidence: 99%

“…In a trial of 73 patients with stable plaque psoriasis, once-daily tazarotene 0.1% gel plus mometasone furoate 0.1% cream was more effective than twice-daily steroid alone Tazarotene is a topical retinoid that normalizes keratinocyte differentiation and has efficacy similar to potent topical steroids, calcipotriol and coal tar, with especially good efficacy in thick fingernail psoriatic lesions Tazarotene monotherapy is limited by skin irritation, which can be reduced when used in combination with other topical therapies www.futuremedicine.com (p < 0.05) [51]. Tazarotene in combination with betamethasone valerate or calcipotriene is another option [39][40][41]. Tazarotene has also been used to potentiate phototherapy [46][47][48][49].…”

Section: Tazarotenementioning

confidence: 99%