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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05758259
• Other study ID #: KET-922/2022
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: February 16, 2023
• Est. completion date: October 2023

Study information

• Verified date: March 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 105
• Est. completion date: October 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Men and women diagnosed with moderate or severe acne vulgaris
• Aged over 18-50 years.
• During the study, were willing not to use skin care products either in oral and/or topical form on the face, as well as other treatments outside of standard AV treatment.
• Willing to take part in the examination and treatment in accordance with the provisions of the study and follow the control time schedule in accordance with the predetermined research plan also willing to sign the informed consent form.

Exclusion Criteria:

• Women who are pregnant and breastfeeding.
• Have history using topical antibiotics in the past 2 weeks.
• Have history using topical corticosteroids in the past 2 weeks.
• Have history taking vitamin D supplements in the last 1 month.
• Have history taking oral antibiotics in the last 1 month.
• Have history using oral corticosteroid use in the last 1 month.
• Have history using oral and topical retinoid use in the last 3 months.
• Have history using topical BPO in the last 1 month.
• Using hormonal contraception for women.
• Have history of drug allergies or skin disorders due to side effects of first-line therapy drugs for moderate/severe acne vulgaris.
• Impaired liver and kidney function.

Related Conditions & MeSH terms

• Acne Vulgaris
• Vitamin D

Intervention

Drug:
• combination oral and topical vitamin D
combination vitamin D 2000 IU 1x1 and topical 7-Dehydrocholesterol 5000 mcg 2x1
• oral placebo and topical cholecalciferol
oral placebo and topical 7-Dehydrocholesterol 5000 mcg 2x1
• oral placebo and basic ingredient placebo topical vitamin D
oral placebo and basic ingredient placebo topical vitamin D similar to the ointment

Locations

Country	Name	City	State
Indonesia	RSUPN Dr. Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement	Changes in counts of inflammation and non-inflammation lesions (assessed in week 8th)	baseline and week 8th
Primary	Existence in VDR expression on acne lesion	VDR count on CD 45 flowcytometry	baseline
Primary	Changes from baseline in IL-1ß expression on acne lesion	IL-1ß expression in pg/mL	baseline and week 8th
Primary	Changes from baseline in IL-6 expression on acne lesion	IL-6 expression in pg/mL	baseline and week 8th
Primary	Changes from baseline in IL-10 expression on acne lesion	IL-10 expression in pg/mL	baseline and week 8th
Primary	Changes from baseline in IL-17 expression on acne lesion	IL-17 expression in pg/mL	baseline and week 8th