The Efficacy and Safety of Topical Vitamin D and Supplementation In Acne Vulgaris The Study of VDR, IL-1β, IL-6, IL-10 and IL-17 Expression

Summary

Introduction This document is a clinical trial protocol. This research will be conducted based on the standards of the Good Clinical Trial Method and regulations from the relevant institutions and ethics committees.

Background Acne vulgaris (AV) is a chronic inflammatory disease with multifactorial causes in the skin's pilosebaceous follicular units, with clinical manifestations in the form of comedones, papules, pustules, nodes, and pseudocysts. The following factors are considered important for the etiology of AV: increased rate of sebum excretion, endocrinological factors such as androgens, abnormal keratinization of the follicular infundibulum, the proliferation of Cutibacterium acnes (C. acnes), and inflammation. Recent studies at the molecular and cellular levels have clarified how these factors interact and the role of the innate immune system. Inflammatory processes have been demonstrated in all types of lesions - preclinical microcomedones, comedones, inflammatory lesions, 'post inflammatory' erythema or hyperpigmentation, and scarring. Inflammation localized to the pilosebaceous can be considered a hallmark of acne and should be managed through several therapeutic routes. Clinicians tend to think that oral antibiotics should be used to treat inflammation in acne. However, this treatment are associated with resistance and low outcome due to its adverse events such as erythema, desquamation, and dry skin. There is evidence of the use and opportunity of vitamin D as a novelty treatment influencing the immune system. 25OHD and 1,25(OH)2D are both catabolized by CYP24A1. 1,25(OH)2D is a ligand for the vitamin D receptor (VDR), a transcription factor that binds to sites in DNA called vitamin D response elements (VDRE). Thousands of these binding sites regulate hundreds of genes through several signaling pathways in different cell types, including their regulation in immune cells by toll-like receptors (TLRs), the primary signaling nucleus of C. acnes that interacts with the innate immune system, causing acute and chronic inflammation.

Study Objectives Primary Objective The primary objective of this study is to evaluate the efficacy and safety of combination topical vitamin D and supplementation as adjuvant therapy in acne vulgaris compared to placebo and topical vitamin D monotherapy.

Secondary Objective(s) To assess Vitamin D Receptor (VDR) expression on acne lesion and blood sample To assess the effect of combination topical vitamin D and supplementation on IL-1β expression on acne lesion To assess the effect of combination topical vitamin D and supplementation on IL-6 expression on acne lesion To assess the effect of combination topical vitamin D and supplementation on IL-10 expression on acne lesion To assess the effect of combination topical vitamin D and supplementation on IL-17 expression on acne lesion

Conditions

• Acne Vulgaris
• Vitamin D

Interventions

DRUG

combination oral and topical vitamin D

combination vitamin D 2000 IU 1x1 and topical 7-Dehydrocholesterol 5000 mcg 2x1

DRUG

oral placebo and topical cholecalciferol

oral placebo and topical 7-Dehydrocholesterol 5000 mcg 2x1

DRUG

oral placebo and basic ingredient placebo topical vitamin D

oral placebo and basic ingredient placebo topical vitamin D similar to the ointment

Sponsors & Collaborators

• Indonesia University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-16

Primary Completion

2023-08-31

Completion

2023-10-31

Countries

• Indonesia

Study Locations