T Sanjay Kumar Menon, Jude Ernest Dileep, Sheela Kuruvila, Damayandhi Kaliyaperumal, Ilakkia Priya Sadasivam, Sushmitha Dharanisankar, Gayathri Jayabalan, Divya Mani
{"title":"局部三联与局部曲安奈德治疗瘢痕疙瘩的疗效和安全性:一项随机对照试验。","authors":"T Sanjay Kumar Menon, Jude Ernest Dileep, Sheela Kuruvila, Damayandhi Kaliyaperumal, Ilakkia Priya Sadasivam, Sushmitha Dharanisankar, Gayathri Jayabalan, Divya Mani","doi":"10.25259/IJDVL_1263_2024","DOIUrl":null,"url":null,"abstract":"<p><p>Background Treatment of keloids presents a significant therapeutic challenge due to their tendency to recur and their impact on a patient's quality of life. This randomised controlled trial aimed to compare the effectiveness of intralesional triple combination regimen versus intralesional triamcinolone acetonide monotherapy in treating keloids. Aims To compare the efficacy and safety of intralesional triple combination versus intralesional triamcinolone acetonide monotherapy in treating keloids at any site. Methods This study was conducted in the outpatient department of Dermatology, Venereology and Leprosy in a tertiary care hospital at Puducherry. Seventy two patients aged ≥18 years with a clinical diagnosis of keloids of any duration, involving any site and without any prior treatment were included in the study. Patients were randomised into two groups: Group A received intralesional triple combination (triamcinolone acetonide, 5-fluorouracil and hyaluronidase), while Group B received intralesional triamcinolone acetonide monotherapy. Treatments were administered every three weeks for four sessions or till complete flattening, whichever was earlier. The Vancouver Scar Scale was used for assessment at baseline and every three weeks for four sessions, and monthly for three months post treatment. Results Both groups showed significant improvement in the Vancouver Scar Scale scores at each follow-up compared to baseline. The mean (percentage) improvement in the Vancouver Scar Scale score in Group A was 0.58 ± 0.5 (7.08%) at three weeks, which progressively increased to 4.47 ± 1.29 (54.55%) at the final follow-up. In Group B, the improvement was lesser, with 0.08 ± 0.28 (0.95%) at three weeks, increasing to 3.08 ± 0.81 (36.65%) at the final follow-up. This improvement was significantly more in Group A at all time points compared to Group B (p < 0.05). Post-procedure pain, which lasted for a few hours, was noted in three and two patients in Groups A and B, respectively (p = 0.642). None of the patients had a recurrence of keloids during the study. Limitations Limitations of this study include small sample size, single centre design, short follow-up period, lack of blinding and patient-reported outcome measures, which may impact the generalisability of the findings. Conclusion Intralesional triple combination is more effective than triamcinolone acetonide monotherapy in treating keloids, offering significantly superior improvements in the Vancouver Scar Scale scoring.</p>","PeriodicalId":50376,"journal":{"name":"Indian Journal of Dermatology Venereology & Leprology","volume":" ","pages":"1-7"},"PeriodicalIF":3.2000,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of intralesional triple combination versus intralesional triamcinolone acetonide for the treatment of keloids: A randomised controlled trial.\",\"authors\":\"T Sanjay Kumar Menon, Jude Ernest Dileep, Sheela Kuruvila, Damayandhi Kaliyaperumal, Ilakkia Priya Sadasivam, Sushmitha Dharanisankar, Gayathri Jayabalan, Divya Mani\",\"doi\":\"10.25259/IJDVL_1263_2024\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Background Treatment of keloids presents a significant therapeutic challenge due to their tendency to recur and their impact on a patient's quality of life. This randomised controlled trial aimed to compare the effectiveness of intralesional triple combination regimen versus intralesional triamcinolone acetonide monotherapy in treating keloids. Aims To compare the efficacy and safety of intralesional triple combination versus intralesional triamcinolone acetonide monotherapy in treating keloids at any site. Methods This study was conducted in the outpatient department of Dermatology, Venereology and Leprosy in a tertiary care hospital at Puducherry. Seventy two patients aged ≥18 years with a clinical diagnosis of keloids of any duration, involving any site and without any prior treatment were included in the study. Patients were randomised into two groups: Group A received intralesional triple combination (triamcinolone acetonide, 5-fluorouracil and hyaluronidase), while Group B received intralesional triamcinolone acetonide monotherapy. Treatments were administered every three weeks for four sessions or till complete flattening, whichever was earlier. The Vancouver Scar Scale was used for assessment at baseline and every three weeks for four sessions, and monthly for three months post treatment. Results Both groups showed significant improvement in the Vancouver Scar Scale scores at each follow-up compared to baseline. The mean (percentage) improvement in the Vancouver Scar Scale score in Group A was 0.58 ± 0.5 (7.08%) at three weeks, which progressively increased to 4.47 ± 1.29 (54.55%) at the final follow-up. In Group B, the improvement was lesser, with 0.08 ± 0.28 (0.95%) at three weeks, increasing to 3.08 ± 0.81 (36.65%) at the final follow-up. This improvement was significantly more in Group A at all time points compared to Group B (p < 0.05). Post-procedure pain, which lasted for a few hours, was noted in three and two patients in Groups A and B, respectively (p = 0.642). None of the patients had a recurrence of keloids during the study. Limitations Limitations of this study include small sample size, single centre design, short follow-up period, lack of blinding and patient-reported outcome measures, which may impact the generalisability of the findings. Conclusion Intralesional triple combination is more effective than triamcinolone acetonide monotherapy in treating keloids, offering significantly superior improvements in the Vancouver Scar Scale scoring.</p>\",\"PeriodicalId\":50376,\"journal\":{\"name\":\"Indian Journal of Dermatology Venereology & Leprology\",\"volume\":\" \",\"pages\":\"1-7\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2025-03-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Indian Journal of Dermatology Venereology & Leprology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.25259/IJDVL_1263_2024\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian Journal of Dermatology Venereology & Leprology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.25259/IJDVL_1263_2024","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Efficacy and safety of intralesional triple combination versus intralesional triamcinolone acetonide for the treatment of keloids: A randomised controlled trial.
Background Treatment of keloids presents a significant therapeutic challenge due to their tendency to recur and their impact on a patient's quality of life. This randomised controlled trial aimed to compare the effectiveness of intralesional triple combination regimen versus intralesional triamcinolone acetonide monotherapy in treating keloids. Aims To compare the efficacy and safety of intralesional triple combination versus intralesional triamcinolone acetonide monotherapy in treating keloids at any site. Methods This study was conducted in the outpatient department of Dermatology, Venereology and Leprosy in a tertiary care hospital at Puducherry. Seventy two patients aged ≥18 years with a clinical diagnosis of keloids of any duration, involving any site and without any prior treatment were included in the study. Patients were randomised into two groups: Group A received intralesional triple combination (triamcinolone acetonide, 5-fluorouracil and hyaluronidase), while Group B received intralesional triamcinolone acetonide monotherapy. Treatments were administered every three weeks for four sessions or till complete flattening, whichever was earlier. The Vancouver Scar Scale was used for assessment at baseline and every three weeks for four sessions, and monthly for three months post treatment. Results Both groups showed significant improvement in the Vancouver Scar Scale scores at each follow-up compared to baseline. The mean (percentage) improvement in the Vancouver Scar Scale score in Group A was 0.58 ± 0.5 (7.08%) at three weeks, which progressively increased to 4.47 ± 1.29 (54.55%) at the final follow-up. In Group B, the improvement was lesser, with 0.08 ± 0.28 (0.95%) at three weeks, increasing to 3.08 ± 0.81 (36.65%) at the final follow-up. This improvement was significantly more in Group A at all time points compared to Group B (p < 0.05). Post-procedure pain, which lasted for a few hours, was noted in three and two patients in Groups A and B, respectively (p = 0.642). None of the patients had a recurrence of keloids during the study. Limitations Limitations of this study include small sample size, single centre design, short follow-up period, lack of blinding and patient-reported outcome measures, which may impact the generalisability of the findings. Conclusion Intralesional triple combination is more effective than triamcinolone acetonide monotherapy in treating keloids, offering significantly superior improvements in the Vancouver Scar Scale scoring.
期刊介绍:
The Indian Association of Dermatologists, Venereologists & Leprologists (IADVL) is the national association of Indian medical specialists who manage patients with skin disorders, sexually transmitted infections (STIs) or leprosy. The current member strength of the association is about 3800. The association works for the betterment of the specialty by holding academic meetings, printing a journal and publishing a textbook. The IADVL has several state branches, each with their own office bearers, which function independently within the constitution of the IADVL.
Established in 1940, the Indian Journal of Dermatology, Venereology and Leprology (IJDVL, ISSN 0378-6323) is the official publication of the IADVL (Indian Association of Dermatologists, Venereologists and Leprologists).