Assessment of Adverse Effects and Quality of Life in Sudanese Acne Patients Treated with Oral Isotretinoin: A Descriptive Cross-Sectional Study
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Abstract
Objectives: Oral isotretinoin is an effective treatment for moderate to severe acne but is often associated with systemic side effects and psychological impact. This study assessed adverse effects and quality of life in Sudanese acne patients undergoing isotretinoin therapy. Design: A cross-sectional descriptive study. Methods: The research was carried out from January to March 2023 in private dermatology clinics in Khartoum, Sudan. A purposive sample of 62 acne patients aged 18 years and older who were on oral isotretinoin was recruited. Data were gathered via structured face-to-face interviews using a questionnaire containing demographic, side effects reported, and validated psychometric instruments: the Cardiff Acne Disability Index (CADI) and Skindex-16. Data were analyzed using SPSS. Results: Most participants were women (77.4%) and between 20–30 years old (72.6%). Most were treated with 20 mg/day isotretinoin. Side effects were xerostomia (95.2%), xerosis (93.5%), thirst (82.3%), cheilitis (53.2%), and myalgia (46.8%). Skindex-16 scores indicated moderate impairment: symptoms (44%), emotions (49%), and function (35%). The average CADI score was 7 ± 3, reflecting intermediate psychological burden. Functional scores were significantly related to severe acne, noncompliance with treatment, and dosage. Conclusion: Oral isotretinoin is linked with a variety of side effects and modest psychosocial effect. Periodic monitoring of patient health during treatment is advised.
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Copyright (c) 2025 Ibtihal A. Mohamed, Fatima S. Naim, Mawahib A. Mustafa, Elkhanssa Abdelhameed Ahmed Elhag, Mohammed H. Alnazeer, Kannan O. Ahmed, Bashir A. Yousef
This work is licensed under a Creative Commons Attribution 4.0 International License.
Creative Commons License All articles published in Annals of Medicine and Medical Sciences are licensed under a Creative Commons Attribution 4.0 International License.
Ibtihal A. Mohamed, Department of Pharmacy Practice, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
Department of Pharmacy Practice, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
Fatima S. Naim, Department of Pharmacy Practice, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
Department of Pharmacy Practice, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
Mawahib A. Mustafa, Department of Pharmacy Practice, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
Department of Pharmacy Practice, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
Elkhanssa Abdelhameed Ahmed Elhag, Department of Pharmacy Practice, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
Department of Pharmacy Practice, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
Mohammed H. Alnazeer, Department of Pharmacology, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
Department of Pharmacology, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
Kannan O. Ahmed, Department of Pharmacy Practice, College of Pharmacy, National University of Science and Technology, Muscat, Oman. Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, University of Gezira, Wad Medani, Sudan.
Department of Pharmacy Practice, College of Pharmacy, National University of Science and Technology, Muscat, Oman.
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, University of Gezira, Wad Medani, Sudan.
Bashir A. Yousef, Department of Pharmacology, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan. Department of Clinical Pharmacy and Pharmacology, Ibn Sina College for Medical Studies, Jeddah, Saudi Arabia.
Department of Pharmacology, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.
Department of Clinical Pharmacy and Pharmacology, Ibn Sina College for Medical Studies, Jeddah, Saudi Arabia.
[1] Vasam M, Korutla S, Bohara RA. Acne vulgaris: A review of the pathophysiology, treatment, and recent nanotechnology based advances. Biochem Biophys Rep. 2023;36:101578. https://doi.org/10.1016/j.bbrep.2023.101578
[2] Sutaria AH, Masood S, Saleh HM, et al. Acne Vulgaris. (Updated 2023 Aug 17). In: StatPearls (Internet). Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459173/
[3] Bae IH, Kwak JH, Na CH, Kim MS, Shin BS, Choi H. A Comprehensive Review of the Acne Grading Scale in 2023. Ann Dermatol. 2024;36(2):65-73. doi: 10.5021/ad.23.094.
[4] Kraft J, Freiman A. Management of acne. CMAJ. 2011;183(7):E430-5. https://doi.org/10.1503/cmaj.090374
[5] Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, Desai SR, Druby KM, Freeman EE, Keri JE, Stein Gold LF, Tan JKL, Tollefson MM, Weiss JS, Wu PA, Zaenglein AL, Han JM, Barbieri JS. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024;90(5):1006.e1-1006.e30. https://doi.org/10.1016/j.jaad.2023.12.017
[6] Paichitrojjana A, Paichitrojjana A. Oral Isotretinoin and Its Uses in Dermatology: A Review. Drug Des Devel Ther. 2023;17:2573-2591. https://doi.org/10.2147/DDDT.S427530
[7] Pile HD, Patel P, Sadiq NM. Isotretinoin. (Updated 2025 Mar 4). In: StatPearls (Internet). Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK525949/
[8] Layton A. The use of isotretinoin in acne. Dermatoendocrinol. 2009;1(3):162-9. https://doi.org/10.4161/derm.1.3.9364
[9] Brzezinski P, Borowska K, Chiriac A, Smigielski J. Adverse effects of isotretinoin: A large, retrospective review. Dermatol Ther. 2017;30(4). https://doi.org/10.1111/dth.12483
[10] Kapała J, Lewandowska J, Placek W, Owczarczyk-Saczonek A. Adverse Events in Isotretinoin Therapy: A Single-Arm Meta-Analysis. Int J Environ Res Public Health. 2022;19(11):6463. https://doi.org/10.3390/ijerph19116463
[11] Singer S, Tkachenko E, Sharma P, Barbieri JS, Mostaghimi A. Psychiatric Adverse Events in Patients Taking Isotretinoin as Reported in a Food and Drug Administration Database From 1997 to 2017. JAMA Dermatol. 2019;155(10):1162-1166. https://doi.org/10.1001/jamadermatol.2019.1416
[12] Rajput I, Anjankar VP. Side Effects of Treating Acne Vulgaris with Isotretinoin: A Systematic Review. Cureus. 2024;16(3):e55946. https://doi.org/10.7759/cureus.55946
[13] Motley RJ, Finlay AY. Practical use of a disability index in the routine management of acne. Clin Exp Dermatol. 1992;17(1):1-3. https://doi.org/10.1111/j.1365-2230.1992.tb02521.x
[14] Chren MM, Lasek RJ, Quinn LM, Mostow EN, Zyzanski SJ. Skindex, a quality-of-life measure for patients with skin disease: reliability, validity, and responsiveness. J Invest Dermatol. 1996;107(5):707-13. https://doi.org/10.1111/1523-1747.ep12365600
[15] Tan YJ, Jamil A, Gunabalasingam P. Disease perception, treatment-seeking behaviour and psychosocial impact of acne vulgaris among university students - A cross-sectional study. Malays Fam Physician. 2025;20:3. https://doi.org/10.51866/oa.622
[16] Abu Taleb R, Hannani H, Mojiri ME, Mobarki OA, Daghriri SA, Mosleh AA, Mongri AO, Farji JS, Alzahrani AA, Safhi AM, Farhan OA. Prevalence and Patterns of Cosmetic Dermatological Procedures in Jazan, Saudi Arabia: A Cross-Sectional Study. Cureus. 2024;16(10):e71223. https://doi.org/10.7759/cureus.71223
[17] Collier CN, Harper JC, Cafardi JA, Cantrell WC, Wang W, Foster KW, Elewski BE. The prevalence of acne in adults 20 years and older. J Am Acad Dermatol. 2008;58(1):56-9. https://doi.org/10.1016/j.jaad.2007.06.045
[18] Rao PK, Bhat RM, Nandakishore B, Dandakeri S, Martis J, Kamath GH. Safety and efficacy of low-dose isotretinoin in the treatment of moderate to severe acne vulgaris. Indian J Dermatol. 2014;59(3):316. https://doi.org/10.4103/0019-5154.131455
[19] Gencebay G, Aşkın Ö, Serdaroğlu S. Evaluation of the changes in sebum, moisturization and elasticity in acne vulgaris patients receiving systemic isotretinoin treatment. Cutan Ocul Toxicol. 2021;40(2):140-144. https://doi.org/10.1080/15569527.2021.1922434
[20] Brito Mde F, Sant'Anna IP, Galindo JC, Rosendo LH, Santos JB. Evaluation of clinical adverse effects and laboratory alterations in patients with acne vulgaris treated with oral isotretinoin. An Bras Dermatol. 2010;85(3):331-7. https://doi.org/10.1590/s0365-05962010000300006
[21] Reyes-Hadsall S, Ju T, Keri JE. Use of Oral Supplements and Topical Adjuvants for Isotretinoin-Associated Side Effects: A Narrative Review. Skin Appendage Disord. 2024;10(1):1-9. https://doi.org/10.1159/000533963
[22] Alli N, Yorulmaz A. An unusual side effect of isotretinoin: retinoid dermatitis affecting external urethral meatus. Cutan Ocul Toxicol. 2015;34(2):176-7. https://doi.org/10.3109/15569527.2014.918140
[23] Karaosmanoğlu N, Mülkoğlu C. Analysis of musculoskeletal side effects of oral Isotretinoin treatment: a cross-sectional study. BMC Musculoskelet Disord. 2020;21(1):631. https://doi.org/10.1186/s12891-020-03656-w
[24] Acar EM, Şaş S, Koçak FA. Evaluation of musculoskeletal adverse effects in patients on systemic isotretinoin treatment: A cross-sectional study. Arch Rheumatol. 2021;37(2):223-229. https://doi.org/10.46497/ArchRheumatol.2022.8645
[25] Karadag AS, Ertugrul DT, Takci Z, Bilgili SG, Namuslu M, Ata N, Sekeroglu R. The effect of isotretinoin on retinol-binding protein 4, leptin, adiponectin and insulin resistance in acne vulgaris patients. Dermatology. 2015;230(1):70-4. https://doi.org/10.1159/000367687
[26] Cemil BC, Ayvaz HH, Ozturk G, Ergin C, Akıs HK, Gonul M, Arzuhal E. Effects of isotretinoin on body mass index, serum adiponectin, leptin, and ghrelin levels in acne vulgaris patients. Postepy Dermatol Alergol. 2016;33(4):294-9. https://doi.org/10.5114/pdia.2016.56928
[27] Šimić D, Penavić JZ, Babić D, Gunarić A. Psychological Status and Quality of Life in Acne Patients Treated with Oral Isotretinoin. Psychiatr Danub. 2017;29(Suppl 2):104-110.
[28] Kaymak Y, Taner E, Taner Y. Comparison of depression, anxiety and life quality in acne vulgaris patients who were treated with either isotretinoin or topical agents. Int J Dermatol. 2009;48(1):41-6. https://doi.org/10.1111/j.1365-4632.2009.03806.x
[29] Al-Hawamdeh MI, Al-Ameri M, Lutfi S, Muhtaseb N, Takhayneh R, Awamreh T. Knowledge, Attitude, and Risk Perception in Oral Isotretinoin Use: A Cross-Sectional Study from Jordan. Dermatol Res Pract. 2024;2024:7714527. https://doi.org/10.1155/2024/7714527
[30] Dréno B, Thiboutot D, Gollnick H, Finlay AY, Layton A, Leyden JJ, Leutenegger E, Perez M; Global Alliance to Improve Outcomes in Acne. Large-scale worldwide observational study of adherence with acne therapy. Int J Dermatol. 2010;49(4):448-56. https://doi.org/10.1111/j.1365-4632.2010.04416.x
[31] Jakobi AU, Bircher AJ, Pagnamenta A, Terrani I. Isotretinoin Concerns in Switzerland: A Student-Based Transversal Study. J Clin Med. 2025;14(6):1801. https://doi.org/10.3390/jcm14061801
[32] Ibrahim S, Osman B, Awaad RM, Abdoon I. Acne Vulgaris Relapse in Sudanese Patients Treated with Oral Isotretinoin: Rate and Predictive Factors. J Multidiscip Healthc. 2023;16:839-849. https://doi.org/10.2147/JMDH.S405509
[33] Secrest AM, Hopkins ZH, Frost ZE, Taliercio VL, Edwards LD, Biber JE, Chen SC, Chren MM, Ferris LK, Kean J, Hess R; Dermatology PRO Consortium. Quality of Life Assessed Using Skindex-16 Scores Among Patients with Acne Receiving Isotretinoin Treatment. JAMA Dermatol. 2020;156(10):1098-1106. https://doi.org/10.1001/jamadermatol.2020.2330