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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03866447
Collaborator
(none)
80
Enrollment
2
Arms
17
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2020
Anticipated Study Completion Date :
Mar 1, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. efficacy of topical Vitamin D analogues in treatment of Acne Vulgaris. [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

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ali saleh ali, Dermatology Resident, Assiut University
ClinicalTrials.gov Identifier:
NCT03866447
Other Study ID Numbers:
  • Vitamin D, and Acne
First Posted:
Mar 7, 2019
Last Update Posted:
Mar 12, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acne Vulgaris
Vitamin D
Adapalene

Study Results

No Results Posted as of Mar 12, 2019