drugset / Trial / NCT03866447
Role of Vitamin D and Its Topical Analogues in Pathogenesis and Treatment of Acne Vulgaris
RandomizedParallel-groupOpen-labelTreatment
Summary
Acne vulgaris is a chronic skin disease of the pilosebaceous unit characterized by formation of papules, pustules, comedones, nodules and cysts. It can have a major psychological burden on the patients. It develops due to blockage of the hair follicles. This is thought to occur as a result of the following four abnormal processes: a higher than normal amount of sebum production, excessive deposition of keratin leading to comedo formation, hair follicles' colonization by Propionibacterium acnes (P. acnes) and the local release of pro-inflammatory mediators. Androgens also play a role in pathogenesis either from elevated levels or exacerbated response
Timeline
- Start
- 2019-10-01
- Primary completion
- 2020-11-01
- Completion
- 2021-03-01
Publications
- Background Slaby O, McDowell A, Bruggemann H, Raz A, Demir-Deviren S, Freemont T, Lambert P, Capoor MN. Is IL-1beta Further Evidence for the Role of Propionibacterium acnes in Degenerative Disc Disease? Lessons From the Study of the Inflammatory Skin Condition Acne Vulgaris. Front Cell Infect Microbiol. 2018 Aug 14;8:272. doi: 10.3389/fcimb.2018.00272. eCollection 2018.
- Background Al-Taiar A, AlKhabbaz M, Rahman A, Al-Sabah R, Shaban L, Akhtar S. Plasma 25-Hydroxy Vitamin D is not Associated with Acne Vulgaris. Nutrients. 2018 Oct 17;10(10):1525. doi: 10.3390/nu10101525.
- Background Karimkhani C, Dellavalle RP, Coffeng LE, Flohr C, Hay RJ, Langan SM, Nsoesie EO, Ferrari AJ, Erskine HE, Silverberg JI, Vos T, Naghavi M. Global Skin Disease Morbidity and Mortality: An Update From the Global Burden of Disease Study 2013. JAMA Dermatol. 2017 May 1;153(5):406-412. doi: 10.1001/jamadermatol.2016.5538.
- Background Jia X, Liu J, Chen B, Jin D, Fu Z, Liu H, Du S, Popkin BM, Mendez MA. Differences in nutrient and energy contents of commonly consumed dishes prepared in restaurants v. at home in Hunan Province, China. Public Health Nutr. 2018 May;21(7):1307-1318. doi: 10.1017/S1368980017003779. Epub 2018 Jan 8.
- Background Reichrath J, Zouboulis CC, Vogt T, Holick MF. Targeting the vitamin D endocrine system (VDES) for the management of inflammatory and malignant skin diseases: An historical view and outlook. Rev Endocr Metab Disord. 2016 Sep;17(3):405-417. doi: 10.1007/s11154-016-9353-4.
- Background Rocha MA, Bagatin E. Skin barrier and microbiome in acne. Arch Dermatol Res. 2018 Apr;310(3):181-185. doi: 10.1007/s00403-017-1795-3. Epub 2017 Nov 17.
- Background Cooper AJ, Harris VR. Modern management of acne. Med J Aust. 2017 Jan 16;206(1):41-45. doi: 10.5694/mja16.00516.
- Background Hayashi N, Akamatsu H, Kawashima M; Acne Study Group. Establishment of grading criteria for acne severity. J Dermatol. 2008 May;35(5):255-60. doi: 10.1111/j.1346-8138.2008.00462.x.
- Background Aspray TJ, Bowring C, Fraser W, Gittoes N, Javaid MK, Macdonald H, Patel S, Selby P, Tanna N, Francis RM; National Osteoporosis Society. National Osteoporosis Society vitamin D guideline summary. Age Ageing. 2014 Sep;43(5):592-5. doi: 10.1093/ageing/afu093. Epub 2014 Jul 28.
- Background Blackburn H, Jacobs D Jr. Commentary: Origins and evolution of body mass index (BMI): continuing saga. Int J Epidemiol. 2014 Jun;43(3):665-9. doi: 10.1093/ije/dyu061. Epub 2014 Apr 1. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adapalene | Other / unclassified | 0.1 % | Topical |
| Comparator | Calcipotriol | Small molecule | — | Topical |