Role of Vitamin D and Its Topical Analogues in Pathogenesis and Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Vitamin D analog
Adapalene
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Patients with Acne of any grade.
- Patients between 18 and 45 years old.
Exclusion Criteria:
- Patients below 18 and above 45years.
- Patients with any concomitant Dermatologic or systemic illness
- Patients on any topical or systemic medication within 4 weeks before enrollment.
- Pregnancy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
vitamin D versus placebo
Adapalene versus placebo
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03866447
Brief Title
Role of Vitamin D and Its Topical Analogues in Pathogenesis and Treatment of Acne Vulgaris
Official Title
Vitamin D and Its Topical Analogues: A Possible Role in the Pathogenesis and Treatment of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vitamin D versus placebo
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Adapalene versus placebo
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Vitamin D analog
Intervention Description
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
Intervention Name(s)
Adapalene
Intervention Description
Patients will be clinically and photographically evaluated at baseline and at each follow up visit every
Primary Outcome Measure Information:
Title
efficacy of topical Vitamin D analogues in treatment of Acne Vulgaris.
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Acne of any grade.
Patients between 18 and 45 years old.
Exclusion Criteria:
Patients below 18 and above 45years.
Patients with any concomitant Dermatologic or systemic illness
Patients on any topical or systemic medication within 4 weeks before enrollment.
Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ali Saleh Ali, M.B.B.M
Phone
+201020883180
Email
salehali90@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
radwa mohamed bakr, M.D
Phone
+01119988115
Email
radwabakr2011@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30155445
Citation
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.
Results Reference
background
PubMed Identifier
30336597
Citation
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.
Results Reference
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PubMed Identifier
28249066
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.
Results Reference
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PubMed Identifier
29306339
Citation
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Results Reference
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PubMed Identifier
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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. doi: 10.1007/s11154-016-9353-4.
Results Reference
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PubMed Identifier
29147769
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.
Results Reference
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PubMed Identifier
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Citation
Cooper AJ, Harris VR. Modern management of acne. Med J Aust. 2017 Jan 16;206(1):41-45. doi: 10.5694/mja16.00516.
Results Reference
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PubMed Identifier
18477223
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.
Results Reference
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PubMed Identifier
25074538
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.
Results Reference
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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. No abstract available.
Results Reference
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Role of Vitamin D and Its Topical Analogues in Pathogenesis and Treatment of Acne Vulgaris
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