Main Article Content

Nyoman Rudi Kusuma
Nanik Sulistyani
Nining Sugihartini

Page: 1355-1361

Abstract

Background: Butterfly pea flower (Clitoria ternatea) contains high levels of anthocyanins with potent antioxidant activity, making it a promising natural ingredient for sunscreen formulations. However, the skin safety of sunscreen spray containing this extract must be evaluated before cosmetic application. Objective: This study aimed to evaluate the skin irritation potential of sunscreen spray formulations containing butterfly pea flower extract using the patch test method. Methods: A patch test was conducted on 15 male Wistar rats. The test materials included sunscreen spray formulations with butterfly pea flower extract at concentrations of 1% (F1), 2% (F2), and 3% (F3). A base formulation without extract (F0) served as a negative control, and sodium lauryl sulfate served as a positive control. Erythema and edema scores were observed at 24, 48, and 72 hours after application. Results: The mean erythema and edema scores for formulations F1, F2, and F3 were 0.0 ± 0, indicating no signs of skin irritation in all tested groups. The positive control group showed slight erythema (score 2.33 ± 0.5), confirming the validity of the test method. Conclusion: Sunscreen spray formulations containing butterfly pea flower extract at concentrations of 1%, 2%, and 3% did not induce skin irritation in male Wistar rats under the patch test conditions. These findings support the potential of butterfly pea flower extract as a safe natural ingredient for sunscreen products.

Downloads

Download data is not yet available.

Article Details

How to Cite
Kusuma, N. R., Sulistyani , N., & Sugihartini , N. (2026). The Evaluation of Skin Irritation Potential of a Butterfly Pea (Clitoria ternatea) Extract Sunscreen Spray Using the Patch Test Method. Journal of Pharmaceutical and Sciences, 9(2), 1355–1361. https://doi.org/10.36490/journal-jps.com.v9i2.1281
Section
Original Articles

References

K. J. Gromkowska-Kępka, A. Puścion-Jakubik, R. Markiewicz-Żukowska, and K. Socha, “The impact of ultraviolet radiation on skin photoaging — review of in vitro studies,” J. Cosmet. Dermatol., vol. 20, no. 11, pp. 3427–3431, 2021, doi: 10.1111/jocd.14033.

L. L. Guan, H. W. Lim, and T. F. Mohammad, “Sunscreens and Photoaging : A Review of Current Literature,” Am. J. Clin. Dermatol., vol. 22, no. 6, pp. 819–828, 2021, doi: 10.1007/s40257-021-00632-5.

M. D. Barma, M. A. Indiran, P. K. Rathinavelu, and D. Srisakthi, “Anti-inflammatory and antioxidant activity of Clitoria ternatea extract mediated selenium nanoparticles,” Int. J. Health Sci. (Qassim)., no. March, pp. 2605–2613, 2022, doi: 10.53730/ijhs.v6ns1.5329.

K. L. GS, Chakraborthy, Kumar V, Gupta S, Kumar A, Gautam N, “Phytochemical and Pharmacological Aspects of Clitoria Ternatea- a Review,” J. Appl. Pharm. Sci. Res., no. July 2018, pp. 3–9, 2018, doi: 10.31069/japsr.v1i2.13061.

O. Ocde, “Acute Dermal Irritation / Corrosion,” no. July, pp. 1–8, 2015.

W. Steiling, “Safety evaluation of cosmetic ingredients regarding their skin sensitization potential,” Cosmetics, vol. 3, no. 2, 2016, doi: 10.3390/cosmetics3020014.

I. Bialas, S. Zelent-Kraciuk, and K. Jurowski, “The skin sensitisation of cosmetic ingredients: review of actual regulatory status,” Toxics, vol. 11, no. 4, p. 392, 2023.

J. P. M. and M. K. R. David A. Basketter, Michel York, “Contact Dermatitis - 2004 - Basketter - Determination of skin irritation potential in the human 4‐h patch test.pdf.” pp. 1–4, 2004.

OECD, “In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, OECD Guidelines for the Testing of Chemicals,” no. 439, 2021.

W. H. Yu, D. Moore, R. J. Debs, M. Kashani-Sabet, D. Liggitt, and T. D. Heath, “Topical gene delivery to murine skin,” J. Invest. Dermatol., vol. 112, no. 3, pp. 370–375, 1999.

A. Teichmann et al., “Differential stripping: determination of the amount of topically applied substances penetrated into the hair follicles,” J. Invest. Dermatol., vol. 125, no. 2, pp. 264–269, 2005.

H. Ridha-Salman, A. A. Al-Zubaidy, A. H. Abbas, D. M. Hassan, and S. A. Malik, “The alleviative effects of canagliflozin on imiquimod-induced mouse model of psoriasis-like inflammation,” Naunyn. Schmiedebergs. Arch. Pharmacol., vol. 398, no. 3, pp. 2695–2715, 2025.

T. Ma et al., “Compound Platycladus orientalis Tincture Promotes Hair Regrowth and Is Associated with Hair-Cycle Progression and Wnt/β-Catenin-Related Signaling,” J. Ethnopharmacol., p. 121692, 2026.

S. Kim et al., “Evaluation of Artificial Intelligence‐Assisted Diagnosis of Skin Erythema in a Patch Test,” Contact Dermatitis, vol. 93, no. 5, pp. 370–378, 2025.

K. Yeerong et al., “Skin evaluation of turmeric/epigallocatechin-3-gallate emulgel for skin irritation and sensitisation effects in healthy Thai participants (TULIP): a protocol for a randomised, double-blind, placebo-controlled trial,” BMJ Open, vol. 15, no. 7, p. e103571, 2025.

C. Imphat and N. Woottisin, “Formulation and Topical Safety Evaluation of Zanthoxylum rhetsa Spray Containing Essential Oil from Pericarp: A Phase 1, Double-blind, Non-Randomized, Single-Arm Patch Test Trial.,” Trop. J. Nat. Prod. Res., vol. 9, no. 10, 2025.

T. S. Sari, T. E. Munandar, H.-I. Chang, I. Sholikhah, and R. Widyowati, “Formulation and Physicochemical Evaluation of Nanoemulgel Star Anise Essential Oil (Illicium verum Hook. f.) and Butterfly Pea Extract (Clitoria ternatea L.) as Antioxidant Cosmetics,” Trends Sci., vol. 22, no. 11, p. 10166, 2025.

Ariyanti, E. Masruriati, N. Lindawati, D. Setyowati, and F. Nurulita, “Uji Sunscreen Buah Tomat (Licopersicon esculentum Mill),” Pros. Semin. Inf. Kesehat. Nas., pp. 91–102, 2022.

R. K. Trivedi, D. Kumar, A. Semwal, V. Joshi, and S. Mukhopadhyay, “A comprehensive overview of sunscreen cream: key actives and methods of formulation,” IJBS, vol. 7, no. 6, pp. 391–407, 2025.

A. R. Saputri, A. H. Fauzia, A. Khoirunnisa, M. Az-Zahra, and D. V. Pertiwi, “Formulasi dan Uji Iritasi Tabir Surya dengan Kandungan Aktif Pati Umbi Porang (Amorphophallus oncophyllus),” JPSCR J. Pharm. Sci. Clin. Res., vol. 9, no. 1, p. 93, 2024, doi: 10.20961/jpscr.v9i1.79432.

A. Sinha, S. Sagar, M. Madhumathy, and W. J. Osborne, “Probiotic bacteria in wound healing; an in-vivo study,” Iran. J. Biotechnol., vol. 17, no. 4, pp. 11–15, 2019, doi: 10.30498/ijb.2019.85188.

D. Leskur et al., “Anatomical site differences of SLS‐induced ICD,” Br. J. Dermatol., vol. 181, no. 1, p. 17633, 2019, doi: 10.1111/bjd.18060.

D. Basketter, M. Liebsch, H. Bendov, M. Marriott, and J. Dagmar, “Comparison of human skin irritation patch test data with in vitro skin irritation assays,” Contact Dermatitis, pp. 109–116, 2010.

R. Kong et al., “A comparative study of the effects of retinol and retinoic acid on histological, molecular, and clinical properties of human skin,” J. Cosmet. Dermatol., vol. 15, pp. 49–57, 2015, doi: 10.1111/jocd.12193.