Clinical and safety outcomes of a prospective, eight-week and monocentric study of a multi-active topical serum in facial hyperpigmentation in Indian skin
DOI:
https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20262843Keywords:
Facial hyperpigmentation, Facial hyperpigmentation serum, Hyperpigmentation treatmentAbstract
Background: Facial hyperpigmentation is a common dermatological concern in individuals with Fitzpatrick skin phototypes III-IV. Current treatment options are often limited by tolerability issues and restrictions on long-term hydroquinone use. This study evaluated the efficacy and safety of SOLGLO-AZ Serum, a hydroquinone-free multi-active topical formulation, in Indian adults with facial hyperpigmentation.
Methods: In this prospective, open-label, monocentric study, 34 adults with facial hyperpigmentation were enrolled, of whom 32 completed the study. Participants applied SOLGLO-AZ serum once nightly for 8 weeks. Efficacy was assessed at baseline, day 30, and day 60 using clinical blemish scores and Antera 3D imaging-derived skin luminance (L*) and pigmentation indices. Safety and participant satisfaction were evaluated using clinical assessments and self-assessment questionnaires.
Results: By day 60, mean blemish scores decreased by 25% (p<0.05), skin luminance (L*) increased by 18.8% (p<0.05), and mean pigmentation values decreased by 9.2% (p<0.05) compared with baseline. More than 93% of participants reported improvement in pigmentation, skin tone evenness, overall appearance, and satisfaction with the product. No clinically significant adverse events, erythema, edema, or irritation were observed.
Conclusions: Once-nightly application of SOLGLO-AZ Serum for 8 weeks resulted in significant improvement in facial hyperpigmentation, high patient satisfaction, and excellent tolerability in Indian adults with Fitzpatrick skin phototypes III–IV. These findings support the use of hydroquinone-free multi-active topical formulations for the management of facial hyperpigmentation.
References
Sood R, Tiwari P. Melasma management: Unveiling recent breakthroughs through literature analysis. Health Sci Rev. 2025;14:100213. DOI: https://doi.org/10.1016/j.hsr.2025.100213
Goel A TN. Current updates on melasma treatments. CosmoDerma 2023;3:79. DOI: https://doi.org/10.25259/CSDM_84_2023
Khanna N, Rasool S. Facial melanoses: Indian perspective. Indian J Dermatol Venereol Leprol. 2011;77(5):552-63. DOI: https://doi.org/10.4103/0378-6323.84046
KrupaShankar DS, Somani VK, Kohli M, Sharad J, Ganjoo A, Kandhari S, et al. A cross-sectional, multicentric clinico-epidemiological study of melasma in India. Dermatol Ther (Heidelb). 2014;4(1):71-81. DOI: https://doi.org/10.1007/s13555-014-0046-1
Sarkar R, Ailawadi P, Garg S. Melasma in Men: A Review of Clinical, Etiological, and Management Issues. J Clin Aesthet Dermatol. 2018;11(2):53-9.
Davis EC, Callender VD. Postinflammatory hyperpigmentation: a review of the epidemiology, clinical features, and treatment options in skin of color. J Clin Aesthet Dermatol. 2010;3(7):20-31.
Handel AC, Miot LD, Miot HA. Melasma: a clinical and epidemiological review. An Bras Dermatol. 2014;89(5):771-82. DOI: https://doi.org/10.1590/abd1806-4841.20143063
Choi W, Yin L, Smuda C, Batzer J, Hearing VJ, Kolbe L. Molecular and histological characterization of age spots. Exp Dermatol. 2017;26(3):242-8. DOI: https://doi.org/10.1111/exd.13203
Wang JY, Kabakova M, Philip R, Stolyar J, Berger-Gutierrez R, Jagdeo J. The Impact of Hyperpigmentation on the Lives of Patients. J Drugs Dermatol. 2025;24(7):668-74. DOI: https://doi.org/10.36849/JDD.8519
Moolla S, Miller-Monthrope Y. Dermatology: how to manage facial hyperpigmentation in skin of colour. Drugs Context. 2022;11:10. DOI: https://doi.org/10.7573/dic.2021-11-2
Fabian IM, Sinnathamby ES, Flanagan CJ, Lindberg A, Tynes B, Kelkar RA, et al. Topical Hydroquinone for Hyperpigmentation: A Narrative Review. Cureus. 2023;15(11):e48840. DOI: https://doi.org/10.7759/cureus.48840
Patil R, Dhoot D, Balasubramanian A, Patil S, Barkate H. Comparison of the Effectiveness and Safety of 5% Cysteamine and 2% Kojic Acid Creams in the Treatment of Melasma in Indian Adult Females. Cureus. 2025;17(3):e81330. DOI: https://doi.org/10.7759/cureus.81330
Furmanczyk M, Brown A, Bustos J, de Henestrosa ARF, Trullas C, Granger C, et al. Efficacy and tolerability of a depigmenting gel serum comprising tranexamic acid, niacinamide, 4-butylresorcinol, phytic acid, and a mixture of hydroxy acids that targets the biological processes regulating skin melanogenesis. J Cosmet Dermatol. 2024;23(6):2058-65. DOI: https://doi.org/10.1111/jocd.16148
Ghasemiyeh P, Fazlinejad R, Kiafar MR, Rasekh S, Mokhtarzadegan M, Mohammadi-Samani S. Different therapeutic approaches in melasma: advances and limitations. Front Pharmacol. 2024;15:1337282. DOI: https://doi.org/10.3389/fphar.2024.1337282
Sarkar R, Gokhale N, Godse K, Ailawadi P, Arya L, Sarma N, et al. Medical Management of Melasma: A Review with Consensus Recommendations by Indian Pigmentary Expert Group. Indian J Dermatol. 2017;62(6):558-77. DOI: https://doi.org/10.4103/ijd.IJD_489_17
Austin E, Nguyen JK, Jagdeo J. Topical Treatments for Melasma: A Systematic Review of Randomized Controlled Trials. J Drugs Dermatol. 2019;18(11):1.
Kusumawardani A, Paramitasari A, Dewi S, Betaubun A. The application of liposomal azelaic acid, 4-n butyl resorcinol and retinol serum enhanced by microneedling for treatment of malar pattern melasma: A case series. Dermatol Rep. 2019;11:8075. DOI: https://doi.org/10.4081/dr.2019.8075
Akl EM. Liposomal azelaic acid 20% cream vs hydroquinone 4% cream as adjuvant to oral tranexamic acid in melasma: a comparative study. J Dermatolog Treat. 2022;33(4):2008-13. DOI: https://doi.org/10.1080/09546634.2021.1905765
Desai S, Ayres E, Bak H, Manco M, Lynch S, Raab S, et al. Effect of a Tranexamic Acid, Kojic Acid, and Niacinamide Containing Serum on Facial Dyschromia: A Clinical Evaluation. J Drugs Dermatol. 2019;18(5):454-9.
Madan Mohan NT, Gowda A, Jaiswal AK, Sharath Kumar BC, Shilpashree P, Gangaboraiah B, et al. Assessment of efficacy, safety, and tolerability of 4-n-butylresorcinol 0.3% cream: an Indian multicentric study on melasma. Clin Cosmet Investig Dermatol. 2016;9:21-7. DOI: https://doi.org/10.2147/CCID.S89451
Khuraiya S, Kachhawa D, Chouhan B, Dua M, Rao P. A comparative study of topical 5% tranexamic acid and triple combination therapy for the treatment of melasma in Indian population. Pigment Int. 2019;6(1):1. DOI: https://doi.org/10.4103/Pigmentinternational.Pigmentinternational_26_17
Bansal C, Naik H, Kar HK, Chauhan A. A Comparison of Low-Fluence 1064-nm Q-Switched Nd: YAG Laser with Topical 20% Azelaic Acid Cream and their Combination in Melasma in Indian Patients. J Cutan Aesthet Surg. 2012;5(4):266-72. DOI: https://doi.org/10.4103/0974-2077.104915
Janney MS, Subramaniyan R, Dabas R, Lal S, Das NM, Godara SK. A Randomized Controlled Study Comparing the Efficacy of Topical 5% Tranexamic Acid Solution versus 3% Hydroquinone Cream in Melasma. J Cutan Aesthet Surg. 2019;12(1):63-7. DOI: https://doi.org/10.4103/JCAS.JCAS_40_18
Patil SS, Deshmukh AR. Comparative study of efficacy of intradermal tranexamic acid versus topical tranexamic acid versus triple combination in melasma. Pigment Int. 2019;6(2):84-95. DOI: https://doi.org/10.4103/Pigmentinternational.Pigmentinternational_19_19
Konisky H, Balazic E, Jaller JA, Khanna U, Kobets K. Tranexamic acid in melasma: A focused review on drug administration routes. J Cosmet Dermatol. 2023;22(4):1197-206. DOI: https://doi.org/10.1111/jocd.15589
D'Mello SA, Finlay GJ, Baguley BC, Askarian-Amiri ME. Signaling Pathways in Melanogenesis. Int J Mol Sci. 2016;17(7):1144. DOI: https://doi.org/10.3390/ijms17071144
Khemis A, Kaiafa A, Queille-Roussel C, Duteil L, Ortonne JP. Evaluation of efficacy and safety of rucinol serum in patients with melasma: a randomized controlled trial. Br J Dermatol. 2007;156(5):997-1004. DOI: https://doi.org/10.1111/j.1365-2133.2007.07814.x
Hakozaki T, Minwalla L, Zhuang J, Chhoa M, Matsubara A, Miyamoto K, et al. The effect of niaciamide on reducing cutaneous pigmentation and suppression of melanosome transfer. Brit J Dermatol. 2002;147:20-31. DOI: https://doi.org/10.1046/j.1365-2133.2002.04834.x
Godse K, Sarkar R, Mysore V, Shenoy MM, Chatterjee M, Damisetty R, et al. Oral Tranexamic Acid for the Treatment of Melasma: Evidence and Experience-Based Consensus Statement from Indian Experts. Indian J Dermatol. 2023;68(2):178-85. DOI: https://doi.org/10.4103/ijd.ijd_266_22
Shahzeb H, Christian P, Junaid B, Sean R, Zonair K, Ali M, et al. Saccharomyces cerevisiae as a skin physiology, pathology, and treatment model. Dermatol Online J. 2020;26(11):13030. DOI: https://doi.org/10.5070/D32611048118
Marta S, Magdalena Anna M, Halina Maria E, Beata K, Elżbieta S, Agnieszka S. Vitis vinifera (Vine Grape) as a Valuable Cosmetic Raw Material. Pharmaceutics. 2023;15(5):1372. DOI: https://doi.org/10.3390/pharmaceutics15051372
Ana Sofia Ferreira R, Marilene E, Oliveira MBPP, Jos M, Sousa L. Main Benefits and Applicability of Plant Extracts in Skin Care Products. Cosmetics. 2015;2:48-65. DOI: https://doi.org/10.3390/cosmetics2020048
Irene D, Sonia L. The New Challenge of Green Cosmetics: Natural Food Ingredients for Cosmetic Formulations. Molecules. 2021;26(13):3921. DOI: https://doi.org/10.3390/molecules26133921
Agata W. Cosmetic and Pharmaceutic Products with Selected Natural and Synthetic Substances for Melasma Treatment and Methods of Their Analysis. Cosmetics. 2023;10(3):86. DOI: https://doi.org/10.3390/cosmetics10030086
Saerom K, Hye-Ryung C, Yoon-Jeong K, Yoon-Sik L, Kyoung-Chan P, Seonyeong K. Milk Protein-Derived Antioxidant Tetrapeptides as Potential Hypopigmenting Agents. Antioxidants. 2020;9(11):1106. DOI: https://doi.org/10.3390/antiox9111106
Xiaoling Z, Yi C, Hedan Y, Hui D, Pingping C, Yiping G, et al. Plasma Metabolomics Indicates Potential Biomarkers and Abnormal Metabolic Pathways in Female Melasma Patients. Ann Dermatol. 2024;36:300- 9. DOI: https://doi.org/10.5021/ad.23.141
Sarkar R, Arora P, Garg KV. Cosmeceuticals for Hyperpigmentation: What is Available? J Cutan Aesthet Surg. 2013;6(1):4-11. DOI: https://doi.org/10.4103/0974-2077.110089
Gupta AK, Gover MD, Nouri K, Taylor S. The treatment of melasma: a review of clinical trials. J Am Acad Dermatol. 2006;55(6):1048-65. DOI: https://doi.org/10.1016/j.jaad.2006.02.009
Downloads
Published
How to Cite
Issue
Section
