A Double-Blind, Randomized Clinical Trial of Niacinamide 4% versus Hydroquinone 4% in the Treatment of Melasma

Josefina Navarrete-Solís, Juan Pablo Castanedo-Cázares, Bertha Torres-Álvarez, Cuauhtemoc Oros-Ovalle, Cornelia Fuentes-Ahumada, Francisco Javier González, Juan David Martínez-Ramírez, Benjamin Moncada, Josefina Navarrete-Solís, Juan Pablo Castanedo-Cázares, Bertha Torres-Álvarez, Cuauhtemoc Oros-Ovalle, Cornelia Fuentes-Ahumada, Francisco Javier González, Juan David Martínez-Ramírez, Benjamin Moncada

Abstract

Background. Multiple modalities have been used in the treatment of melasma with variable success. Niacinamide has anti-inflammatory properties and is able to decrease the transfer of melanosomes. Objective. To evaluate the therapeutic effect of topical niacinamide versus hydroquinone (HQ) in melasma patients. Patients and Methods. Twenty-seven melasma patients were randomized to receive for eight weeks 4% niacinamide cream on one side of the face, and 4% HQ cream on the other. Sunscreen was applied along the observation period. They were assessed by noninvasive techniques for the evaluation of skin color, as well as subjective scales and histological sections initially and after the treatment with niacinamide. Results. All patients showed pigment improvement with both treatments. Colorimetric measures did not show statistical differences between both sides. However, good to excellent improvement was observed with niacinamide in 44% of patients, compared to 55% with HQ. Niacinamide reduced importantly the mast cell infiltrate and showed improvement of solar elastosis in melasma skin. Side effects were present in 18% with niacinamide versus 29% with HQ. Conclusion. Niacinamide induces a decrease in pigmentation, inflammatory infiltrate, and solar elastosis. Niacinamide is a safe and effective therapeutic agent for this condition.

Figures

Figure 1
Figure 1
Right side treated with niacinamide. View at onset and 8 weeks later with an excellent decrease in pigmentation.
Figure 2
Figure 2
Left side treated with HQ: Onset and 8 weeks later with an excellent improvement.
Figure 3
Figure 3
Physicians Global Assessment in melasma patients with niacinamide versus HQ.
Figure 4
Figure 4
Epidermal pigmentation reduction. (a) Basal melasma skin biopsy, (b) skin biopsy posttreated with niacinamide. (Fontana Masson, original magnification 40x). Below is shown the measured positive areas for melanin using a computer-assisted image analysis program.

References

    1. Hernández-Barrera R, Torres-Alvarez B, Castanedo-Cázares JP, Oros-Ovalle C, Moncada B. Solar elastosis and presence of mast cells as key features in the pathogenesis of melasma. Clinical and Experimental Dermatology. 2008;33(3):305–308.
    1. Gupta AK, Gover MD, Nouri K, Taylor S. The treatment of melasma: a review of clinical trials. Journal of the American Academy of Dermatology. 2006;55(6):1048–1065.
    1. Hakozaki T, Minwalla L, Zhuang J, et al. The effect of niacinamide on reducing cutaneous pigmentation and suppression of melanosome transfer. British Journal of Dermatology. 2002;147(1):20–31.
    1. Gensler HL. Prevention of photoimmunosuppression and photocarcinogenesis by topical nicotinamide. Nutrition and Cancer. 1997;29(2):157–162.
    1. Shalita AR, Smith JG, Parish LC, Sofman MS, Chalker DK. Topical nicotinamide compared with clindamycin gel in the treatment of inflammatory acne vulgaris. International Journal of Dermatology. 1995;34(6):434–437.
    1. Wozniacka A, Wieczorkowska M, Gebicki J, Sysa-Jedrzejowska A. Topical application of 1-methylnicotinamide in the treatment of rosacea: a pilot study. Clinical and Experimental Dermatology. 2005;30(6):632–635.
    1. Levine D, Even-Chen Z, Lipets I, et al. Pilot, multicenter, double-blind, randomized placebo-controlled bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis. Journal of the American Academy of Dermatology. 2010;63(5):775–781.
    1. Tanno O, Ota Y, Kitamura N, Katsube T, Inoue S. Nicotinamide increases biosynthesis of ceramides as well as other stratum corneum lipids to improve the epidermal permeability barrier. British Journal of Dermatology. 2000;143(3):524–531.
    1. Chiu PC, Chan CC, Lin HM, Chiu HC. The clinical anti-aging effects of topical kinetin and niacinamide in Asians: a randomized, double-blind, placebo-controlled, split-face comparative trial. Journal of Cosmetic Dermatology. 2007;6(4):243–249.
    1. Pandya A, Berneburg M, Ortonne JP, Picardo M. Guidelines for clinical trials in melasma. British Journal of Dermatology. 2006;156(1):21–28.
    1. Moncada B, Sahagun-Sanchez LK, Torres-Alvarez B, Castanedo-Cazares JP, Martinez-Ramirez JD, Gonzalez FJ. Molecular structure and concentration of melanin in the stratum corneum of patients with melasma. Photodermatology, Photoimmunology and Photomedicine. 2009;25:159–160.
    1. Huang Z, Lui H, Chen XK, Alajlan A, McLean DI, Zeng H. Raman spectroscopy of in vivo cutaneous melanin. Journal of Biomedical Optics. 2004;9(6):1198–1205.
    1. Torres-Álvarez B, Mesa-Garza IG, Castanedo-Cázares JP, et al. Histochemical and immunohistochemical study in melasma: evidence of damage in the Basal membrane. Dermatopathol. 2011;33:291–295.

Source: PubMed

3
구독하다