Effectiveness and safety of a novel topical depigmenting agent in epidermal pigmentation: an open-label, non-comparative study

Authors

  • B. S. Chandrashekar Cutis Academy of Cutaneous Sciences, Bangalore, Karnataka, India
  • Chaithra Shenoy Cutis Academy of Cutaneous Sciences, Bangalore, Karnataka, India
  • Lakshmi Narayana N. Cutis Academy of Cutaneous Sciences, Bangalore, Karnataka, India

DOI:

https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20183378

Keywords:

Arbutin, Dermacatch, Epidermal pigmentation, Fotofinder, Glycolic acid, Kojic acid, Licorice, Niacinamide, Melasma, Soy isoflavones

Abstract

Background: Active compounds isolated from plants are known to inhibit melanogenesis without melanocytotoxicity. The aim of this study was to assess the effectiveness and safety of a cream containing a combination of niacinamide, glycolic acid, vitamin E acetate, kojic acid, soy isoflavones, arbutin, pterowhite, licorice and ascorbyl glucoside for the treatment of epidermal pigmentation.

Methods: Sixty subjects (between 18-45 years) with epidermal pigmentation were enrolled in this 12-week, open-label, non-comparative study. Clinical/dermoscopic aspects (grade-1: <25%; grade-2: 25-50%; grade-3: 50-75%; grade-4: >75% reduction in the amount of epidermal pigment); melanin index/erythema measure (Dermacatch); extent, depth and density of pigmentation (FotoFinder) and safety were assessed.

Results: Out of 60 enrolled subjects, 53 completed the study. Overall percentage of melanin and erythema improvement (Dermacatch) was 24.2% and 7.4% respectively (p<0.05). Based on Fotofinder images, 13% had grade 4 improvement, 47% had grade 3 improvement, 30% had grade 2 improvement while 9% subjects had grade 1 improvement. On the basis of clinical photographic images, 15% had grade 4 improvements in the skin colour, 41% had grade 3, 34% had grade 2 and 9% subjects had grade 1 improvement. Adverse effect of skin irritation was reported in one subject, which resolved after discontinuing the treatment.

Conclusions: Cream containing a combination of niacinamide 4.0%, glycolic acid 2.0%, vitamin E acetate 0.1%, kojic acid dipalmitate 2.0%, soy isoflavones 0.5%, arbutin 2.0%, pterowhite 0.12%, licorice 40% CA 0.12%, ascorbyl glucoside 0.1% was found to be safe and effective in the treatment of epidermal pigmentation.

References

Nouveau S, Agrawal D, Kohli M, Bernerd F, Misra N, Nayak CS. Skin hyperpigmentation in Indian population: Insights and best practice. Indian J Dermatol. 2016;61(5):487-95.

Khanna N, Rasool S. Facial melanoses: Indian perspective. Indian J Dermatol Venereol Leprol. 2011;77(5):552-64.

Sandipan Dhar, Joly Seth, and Deepak Parikh. Systemic Side-Effects of Topical Corticosteroids. Indian J Dermatol. 2014;59(5):460–4.

Smit N, Vicanova J, Pavel S. The Hunt for Natural Skin Whitening Agents. Int J Mol Sci. 2009;10:5326-49.

Zhu W, Gao J. The Use of Botanical Extracts as Topical Skin-Lightening Agents for the Improvement of Skin Pigmentation Disorders. J Investigative Dermatol Symposium Proceedings. 2008;13:20–4.

Maeda K, Fukuda M. Arbutin: Mechanism of its depigmenting action in human melanocyte culture. J Pharmacol Exp Ther. 1996;276:765–9.

Hamed SH, Sriwiriyanont P, deLong MA, Visscher MO, Wickett RR, Boissy RE. Comparative efficacy and safety of deoxyarbutin,a new tyrosinase-inhibiting agent. J Cosmet Sci. 2006;57:291-8.

Lim JT. Treatment of melasma using kojic acid in a gel containing hydroquinone and glycolic acid. Dermatol Surg. 1999;25:282-4.

Garcia A, Fulton JE Jr. The combination of glycolic acid and hydroquinone or kojic acid for the treatment of melasma and related conditions. Dermatol Surg. 1996;22:443-7.

Yokota T, Nishio H, Kubota Y, Mizoguchi M. The inhibitory effect of glabridin from licorice extracts on melanogenesis and inflammation. Pigment Cell Res. 1998;11:355-61.

Amer M, Metwalli M. Topical liquiritin improves melasma. Int J Dermatol. 2000;39:299-301.

Kameyama K, Sakai C, Kondoh S, Yonemoto K, Nishiyama S, Tagawa M, et al. Inhibitory effect of magnesium-L-ascorbyl-2-phosphate on melano-genesis in vitro and in vivo. J Am Acad Dermatol. 1996;34:29-33.

Konda S, Geria AN, Halder RM. New Horizons in Treating Disorders of Hyperpigmentation in Skin of Color. Semin Cutan Med Surg. 2012;31:133-9.

Kindred C, Okereke U, Callender VD. Skin-Lightening Agents: An Overview of Prescription, Office-Dispensed, and Over-the-counter Products. Cutis. 2013;5:18-26.

Wallo W, Nebus J, Leyden JJ. Efficacy of a soy moisturizer in photoaging: A double-blind, vehicle-controlled, 12-week study. J Drugs Dermatol. 2007;6:917–22.

Badreshia-Bansal S, Draelos ZD. Insight into skin lightening cosmeceuticals for women of color. J Drugs Dermatol. 2007;6:32–9.

Hakozaki T, Minwalla L, Zhuang J, Chhoa M, Matsubara A, Miyamoto K, et al. Effect of niacinamide on reducing cutaneous pigmentation and suppression of melanosome transfer. Br J Dermatol 2002;147:20-31.

Draelos ZD, Yatskayer M, Bhushan P, Pillai S, Oresajo C. Evaluation of a kojic acid, emblica extract, and glycolic acid formulation compared with hydroquinone 4% for skin lightening. Cutis. 2010;86(3):153-8.

Un Sun Park, Adilson Costa. Clinical and instrumental assessment of a skin brightening cream containing vitamin C and licorice extract in subjects with melasma. J Am Acad Dermatol. 2013;68(4):188.

Ikeno, Hiroshi. Clinical evaluation of a cream containing kojic acid and licorice extract on hyperpigmentation of the skin. 2000;42:600-5.

Guevara IL, Pandya AG. Safety and efficacy of 4% hydroquinone combined with 10% glycolic acid, antioxidants, and sunscreen in the treatment of melasma. Int J Dermatol. 2003;42(12):966-72.

Downloads

Published

2018-10-25

Issue

Section

Original Research Articles