Role of Vitamin D and Its Topical Analogues in Pathogenesis and Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

Vitamin D and Its Topical Analogues: A Possible Role in the Pathogenesis and Treatment of Acne Vulgaris

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03866447
• Other study ID #: Vitamin D, and Acne
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: ali Saleh Ali, M.B.B.M
• Phone: +201020883180
• Email: salehali90[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

In 2015, acne was estimated to affect 633 million people globally, making it the 8th most common disease worldwide. Acne commonly occurs in adolescence and affects an estimated 80-90% of teenagers. Children and adults may also be affected before and after puberty Many treatment options for acne are available, including lifestyle changes; such as eating healthy, medications (topical and systemic) and medical procedure.Despite of the availability of many therapeutic modalities, none of them has proved to be ideal. Recently, Vitamin D was proved to be an exciting option for treating many chronic inflammatory dermatological diseases. It appears to have systemic antimicrobial and other effects that may be crucial in a variety of both acute and chronic illnesses. Vitamin D regulates the immune system, Furthermore, it has antioxidant and anti-comedogenic properties. So, Vitamin D deficiency maybe involved in the pathogenesis of Acne Vulgaris . Thus,Vitamin D use could potentially reduce inappropriate antibiotic prescription and boost therapeutic response, either as a monotherapy or in combination with other anti-acne medications. High glycemic food intake and excessive consumption of dairy products as well as of saturated fatty acids were all suggested to have an influence on AV course. In addition, obesity has been reported to be associated with acne. Interestingly, genetic studies found out that obesity can drive down vitamin D levels So, there seems to be a theoretical background about the association between Acne Vulgaris, Vitamin D and obesity

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Patients with Acne of any grade.

2. Patients between 18 and 45 years old.

Exclusion Criteria:

1. Patients below 18 and above 45years.

2. Patients with any concomitant Dermatologic or systemic illness

3. Patients on any topical or systemic medication within 4 weeks before enrollment.

4. Pregnancy.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Vitamin D analog
Patients will be clinically and photographically evaluated at baseline and at each follow up visit every month for 3 months. Any local or systemic clinical side effects of the medications will be noted during each follow up visit.
• Adapalene
Patients will be clinically and photographically evaluated at baseline and at each follow up visit every

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

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). pii: E1525. doi: 10.3390/nu10101525. — View Citation

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. — View Citation

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. — View Citation

Cooper AJ, Harris VR. Modern management of acne. Med J Aust. 2017 Jan 16;206(1):41-45. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Slaby O, McDowell A, Brüggemann H, Raz A, Demir-Deviren S, Freemont T, Lambert P, Capoor MN. Is IL-1ß 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of topical Vitamin D analogues in treatment of Acne Vulgaris.	patients will be evaluated before and after treatment with Vitamin D and Adapalene versus placebo(panthenol).patients with acne will be graded according to Facial Acne Severity Scale. This scale is based on half-face counting of inflammatory lesions .Mild 0-5 Moderate 6-20 Severe 21-50 Very severe >50	3 months