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

NCT ID: NCT03866447

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-03-01

Brief 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

Detailed 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

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vitamin D versus placebo

This group will be treated by topical Vitamin D analogue (Calcipotriol) versus placebo (panthenol).split face.half of the face will be treated by vitamin d and the other by placebo(panthenol)

Group Type: ACTIVE_COMPARATOR

Vitamin D analog

Intervention Type: DRUG

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 versus placebo

this group will be treated by topical Adapalene (0.1%) versus versus placebo (panthenol).split face.half of the face will be treated by vitamin d and the other by placebo(panthenol)

Group Type: ACTIVE_COMPARATOR

Adapalene

Intervention Type: DRUG

Patients will be clinically and photographically evaluated at baseline and at each follow up visit every

Interventions

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.

Intervention Type: DRUG

Adapalene

Patients will be clinically and photographically evaluated at baseline and at each follow up visit every

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

ali saleh ali

Dermatology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

ali Saleh Ali, M.B.B.M

Role: CONTACT

salehali90@yahoo.com

+201020883180

radwa mohamed bakr, M.D

Role: CONTACT

radwabakr2011@hotmail.com

+01119988115

References

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.

Reference Type: BACKGROUND

PMID: 30155445 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30336597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28249066 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29306339 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27447175 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29147769 (View on PubMed)

Cooper AJ, Harris VR. Modern management of acne. Med J Aust. 2017 Jan 16;206(1):41-45. doi: 10.5694/mja16.00516.

Reference Type: BACKGROUND

PMID: 28076744 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18477223 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25074538 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24691955 (View on PubMed)

Other Identifiers

Vitamin D, and Acne

Identifier Type: -

Identifier Source: org_study_id