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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

Primary Purpose

Acne Vulgaris, Vitamin D

Status
Enrolling by invitation
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
combination oral and topical vitamin D
oral placebo and topical cholecalciferol
oral placebo and basic ingredient placebo topical vitamin D
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • RSUPN Dr. Cipto Mangunkusumo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

combination vitamin D oral and topical cholecalciferol

oral placebo and topical vitamin D

oral placebo and basic ingredient placebo topical vitamin D

Arm Description

combination topical vitamin D and supplementation Daily supplementation (1x/day, in the morning) and topical application (2x/day, in the morning and in the afternoon, minimum duration 4 hours on the skin) for 56 days Daily supplementation (1x/day, in the morning) and topical application (2x/day, in the morning and in the afternoon, minimum duration 4 hours on the skin) for 56 days

oral placebo and topical vitamin D Daily supplementation (1x/day, in the morning) and topical application (2x/day, in the morning and in the afternoon, minimum duration 4 hours on the skin) for 56 days

Daily supplementation (1x/day, in the morning) and topical application (2x/day, in the morning and in the afternoon, minimum duration 4 hours on the skin) for 56 days

Outcomes

Primary Outcome Measures

Clinical improvement
Changes in counts of inflammation and non-inflammation lesions (assessed in week 8th)
Existence in VDR expression on acne lesion
VDR count on CD 45 flowcytometry
Changes from baseline in IL-1β expression on acne lesion
IL-1β expression in pg/mL
Changes from baseline in IL-6 expression on acne lesion
IL-6 expression in pg/mL
Changes from baseline in IL-10 expression on acne lesion
IL-10 expression in pg/mL
Changes from baseline in IL-17 expression on acne lesion
IL-17 expression in pg/mL

Secondary Outcome Measures

Full Information

First Posted
January 8, 2023
Last Updated
March 4, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05758259
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combination vitamin D oral and topical cholecalciferol
Arm Type
Experimental
Arm Description
combination topical vitamin D and supplementation Daily supplementation (1x/day, in the morning) and topical application (2x/day, in the morning and in the afternoon, minimum duration 4 hours on the skin) for 56 days Daily supplementation (1x/day, in the morning) and topical application (2x/day, in the morning and in the afternoon, minimum duration 4 hours on the skin) for 56 days
Arm Title
oral placebo and topical vitamin D
Arm Type
Active Comparator
Arm Description
oral placebo and topical vitamin D Daily supplementation (1x/day, in the morning) and topical application (2x/day, in the morning and in the afternoon, minimum duration 4 hours on the skin) for 56 days
Arm Title
oral placebo and basic ingredient placebo topical vitamin D
Arm Type
Placebo Comparator
Arm Description
Daily supplementation (1x/day, in the morning) and topical application (2x/day, in the morning and in the afternoon, minimum duration 4 hours on the skin) for 56 days
Intervention Type
Drug
Intervention Name(s)
combination oral and topical vitamin D
Intervention Description
combination vitamin D 2000 IU 1x1 and topical 7-Dehydrocholesterol 5000 mcg 2x1
Intervention Type
Drug
Intervention Name(s)
oral placebo and topical cholecalciferol
Intervention Description
oral placebo and topical 7-Dehydrocholesterol 5000 mcg 2x1
Intervention Type
Drug
Intervention Name(s)
oral placebo and basic ingredient placebo topical vitamin D
Intervention Description
oral placebo and basic ingredient placebo topical vitamin D similar to the ointment
Primary Outcome Measure Information:
Title
Clinical improvement
Description
Changes in counts of inflammation and non-inflammation lesions (assessed in week 8th)
Time Frame
baseline and week 8th
Title
Existence in VDR expression on acne lesion
Description
VDR count on CD 45 flowcytometry
Time Frame
baseline
Title
Changes from baseline in IL-1β expression on acne lesion
Description
IL-1β expression in pg/mL
Time Frame
baseline and week 8th
Title
Changes from baseline in IL-6 expression on acne lesion
Description
IL-6 expression in pg/mL
Time Frame
baseline and week 8th
Title
Changes from baseline in IL-10 expression on acne lesion
Description
IL-10 expression in pg/mL
Time Frame
baseline and week 8th
Title
Changes from baseline in IL-17 expression on acne lesion
Description
IL-17 expression in pg/mL
Time Frame
baseline and week 8th

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
RSUPN Dr. Cipto Mangunkusumo
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
1358
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

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

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