Evaluating the non-comedogenic profile of Venusia Sun Unseen: a prospective, double-blind, randomized and controlled study
DOI:
https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20261930Keywords:
Comedegenicity, Non-comedogenic sunscreen, Microcomedones, Cosmetic safetyAbstract
Background: The comedogenic potential of topical sunscreens is an important consideration for both skin safety and long-term adherence to photoprotective regimens. This study aimed to evaluate the comedogenicity of Venusia Sun Unseen sunscreen under occluded conditions, compared with positive and negative controls.
Methods: A prospective, randomized, double-blind, positive- and negative-controlled, two-cohort parallel-group study was conducted involving 30 healthy adults aged 18 to 55 years with prominent follicular orifices on the upper back. The test sunscreen (Venusia Sun Unseen) was evaluated against coconut oil as the positive (comedogenic) control, and glycerine as the negative (non-comedogenic) control. Products were applied under occlusive patch chambers on three designated sites on the upper back. Follicular biopsies were obtained before and after 12 alternate-day applications over a 4-week period. Microcomedones were graded on a four-point scale using light microscopy. Statistical comparisons were performed using the Mann–Whitney U test.
Results: The method was validated as the positive control showed significantly higher mean comedone grades (2.07±0.84) than the negative control (0.76±0.58; p=0.001). The test product, Venusia Sun Unseen, demonstrated a significantly lower mean comedone grade (0.86±0.95) compared to the positive control (p=0.001), indicating non-comedogenicity. No adverse events related to the test or control products were reported.
Conclusions: Venusia Sun Unseen sunscreen is non-comedogenic and safe when applied topically under occluded conditions.
References
Hegde AR, Kunder MU, Narayanaswamy M, Murugesan S, Furtado SC, Veerabhadraiah BB, et al. Advancements in sunscreen formulations: integrating polyphenolic nanocarriers and nanotechnology for enhanced UV protection. Environ Sci Pollut Res Int. 2024;31(26):38061-82. DOI: https://doi.org/10.1007/s11356-024-33712-0
Ziglar J, Mohammad TF, Gilaberte Y, Lim HW. Sunscreens: Updates on Sunscreen Filters and Formulations. Photodermatol Photoimmunol Photomed. 2025;41(3):e70026. DOI: https://doi.org/10.1111/phpp.70026
Holt EL, Stavros VG. Applications of ultrafast spectroscopy to sunscreen development, from first principles to complex mixtures. Int Rev Phys Chem. 2019;38(2):243-85. DOI: https://doi.org/10.1080/0144235X.2019.1663062
Hayden CGJ, Cross SE, Anderson C, Saunders NA, Roberts MS. Sunscreen penetration of human skin and related keratinocyte toxicity after topical application. Skin Pharmacol Physiol. 2005;18(4):170-4. DOI: https://doi.org/10.1159/000085861
Passeron T, Desai SR, Abdallah M, Al-Niaimi F, Dlova N, Grimes PE, et al. Global consensus on the management of melanin hyperpigmentation disorders. J Eur Acad Dermatol Venereol. 2026;40(5):760-72. DOI: https://doi.org/10.1111/jdv.70185
Kohli M, Srinivas CR, Saraswat A, Ganjoo A, Kathed A, Patel G, et al. Practical Recommendations for Indians on Sunscreen Use-A Modified Delphi Consensus by Indian Sunscreen Forum (PRISM-ISF). J Cosmet Dermatol. 2025;24(9):e70441. DOI: https://doi.org/10.1111/jocd.70441
Ghalla M, Dixit R, Murthy KS, Katta TP. Expert consensus on the use of sunscreen agents: Indian perspective. Int J Res Dermatol. 2021;8(1):168. DOI: https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20214928
Madnani N, Saraswat A, Nott A, Jakhar D, Gupta LK, Kohli M, et al. PRACT-India: Practical Recommendations on Acne Care and Medical Treatment in India-A Modified Delphi Consensus. Antibiotics (Basel). 2025;14(8):844. DOI: https://doi.org/10.3390/antibiotics14080844
Passeron T, Lim HW, Goh CL, Kang HY, Ly F, Morita A, et al. Photoprotection according to skin phototype and dermatoses: practical recommendations from an expert panel. J Eur Acad Dermatol Venereol. 2021;35(7):1460-9. DOI: https://doi.org/10.1111/jdv.17242
Choi K, Liu H, Zhu Y, Jiang Z, Lu S. A case-control study exploring the association between cosmetic use and acne risk: Implications for prevention and clinical practice. Clin Cosmet Investig Dermatol. 2025;18:1833-43. DOI: https://doi.org/10.2147/CCID.S533950
Starzyk T, Aust N, Schur N, Miller R. Comedogenicity in cosmeceuticals: A review of clinical relevance, regulatory gaps, and future directions. JAAD Rev. 2025;6:78-83. DOI: https://doi.org/10.1016/j.jdrv.2025.09.002
Chiba K, Yoshizawa K, Makino I, Kawakami K, Onoue M. Comedogenicity of squalene monohydroperoxide in the skin after topical application. J Toxicol Sci. 2000;25(2):77-83. DOI: https://doi.org/10.2131/jts.25.77
Thielitz A, Helmdach M, Röpke EM, Gollnick H. Lipid analysis of follicular casts from cyanoacrylate strips as a new method for studying therapeutic effects of antiacne agents. Br J Dermatol. 2001;145(1):19-27. DOI: https://doi.org/10.1046/j.1365-2133.2001.04276.x
Gala MYN, Muchhala SS, Charugulla SN, Rathod R, Mane A, Pandit S, et al. Evaluation of comedogenic potential of a moisturizer venusia max lotion (PAMA free). IP Indian J Clin Exp Dermatol. 2022;8(1):28-31. DOI: https://doi.org/10.18231/j.ijced.2022.006
Mills Jr OH, Berger RS. Assessing comedogenicity: current and future trends. Clin Safe Efficacy Test Cosmetics. 1989;83:91.
Mills OH. A human model for assessing comedogenic substances. Arch Dermatol. 1982;118(11):903. DOI: https://doi.org/10.1001/archderm.1982.01650230031022
Draelos ZD, DiNardo JC. A re-evaluation of the comedogenicity concept. J Am Acad Dermatol. 2006;54(3):507-12. DOI: https://doi.org/10.1016/j.jaad.2005.11.1058
Abel Francis AF, Shojan A. Comedogenicity of Oils. Int J Contemp Med Res IJCMR. 2019;6:8. DOI: https://doi.org/10.21276/ijcmr.2019.6.8.21
Gala MY, Muchhala SS, Charugulla SN, Rathod R, Mane A, Pandit S, et al. Evaluation of comedogenic potential of a paraben-free plant-based butter moisturizing cream: A double-blind, comparative study. Cosmoderma. 2021;1:52. DOI: https://doi.org/10.25259/CSDM_53_2021
Schäfer P, Bewick-Sonntag C, Capri MG, Berardesca E. Physiological changes in skin barrier function in relation to occlusion level, exposure time and climatic conditions. Skin Pharmacol Physiol. 2002;15(1):7-19. DOI: https://doi.org/10.1159/000049384
Lindstrom AR, von Schuckmann LA, Hughes MCB, Williams GM, Green AC, van der Pols JC. Regular sunscreen use and risk of mortality: Long-term follow-up of a skin cancer prevention trial. Am J Prev Med. 2019;56(5):742-6. DOI: https://doi.org/10.1016/j.amepre.2018.11.025
Sander M, Sander M, Burbidge T, Beecker J. The efficacy and safety of sunscreen use for the prevention of skin cancer. CMAJ Can Med Assoc J. 2020;192(50):E1802-8. DOI: https://doi.org/10.1503/cmaj.201085
Piquero-Casals J, Morgado-Carrasco D, Rozas-Muñoz E, Mir-Bonafé JF, Trullàs C, Jourdan E, et al. Sun exposure, a relevant exposome factor in acne patients and how photoprotection can improve outcomes. J Cosmet Dermatol. 2023;22(6):1919-28. DOI: https://doi.org/10.1111/jocd.15726
Downloads
Published
How to Cite
Issue
Section
