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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03866447
Recruitment Status : Unknown
Verified March 2019 by ali saleh ali, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
ali saleh ali, Assiut University

Study Description
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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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Vitamin D analog Drug: Adapalene Phase 4

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin D and Its Topical Analogues: A Possible Role in the Pathogenesis and Treatment of Acne Vulgaris
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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)
 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.
Active Comparator: 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)
 Drug: Adapalene
Patients will be clinically and photographically evaluated at baseline and at each follow up visit every


Outcome Measures
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Primary Outcome Measures :
  1. efficacy of topical Vitamin D analogues in treatment of Acne Vulgaris. [ Time Frame: 3 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866447


Contacts
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Contact: ali Saleh Ali, M.B.B.M +201020883180 salehali90@yahoo.com
Contact: radwa mohamed bakr, M.D +01119988115 radwabakr2011@hotmail.com

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: ali saleh ali, Dermatology Resident, Assiut University
ClinicalTrials.gov Identifier: NCT03866447    
Other Study ID Numbers: Vitamin D, and Acne
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Vitamin D
Adapalene
Vitamins
Micronutrients
Physiological Effects of Drugs
 Bone Density Conservation Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents