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
Verified date | March 2023 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | RSUPN Dr. Cipto Mangunkusumo | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04321070 -
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
|
Phase 1 | |
Recruiting |
NCT05755256 -
The Impact of Probiotics on Skin Hydration in Youth With Mild Acne
|
Phase 2 | |
Completed |
NCT05131373 -
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
|
Phase 1 | |
Completed |
NCT01445301 -
Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
|
Phase 3 | |
Completed |
NCT03303170 -
Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris
|
N/A | |
Completed |
NCT04698239 -
Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions.
|
N/A | |
Completed |
NCT02886715 -
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris
|
Phase 3 | |
Terminated |
NCT02924428 -
Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris
|
N/A | |
Not yet recruiting |
NCT02491060 -
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
|
Phase 3 | |
Not yet recruiting |
NCT02535871 -
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
|
Phase 3 | |
Not yet recruiting |
NCT02525822 -
Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris
|
Phase 2 | |
Completed |
NCT02709902 -
Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris
|
Phase 1 | |
Completed |
NCT02913001 -
The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
|
N/A | |
Completed |
NCT02250430 -
A Phase 1 Study Assessing Local Cutaneous Effects of SB204
|
Phase 1 | |
Completed |
NCT01769664 -
A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris
|
Phase 1 | |
Completed |
NCT01694810 -
Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01727440 -
Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment
|
N/A | |
Completed |
NCT01194375 -
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
|
Phase 2 | |
Completed |
NCT02524665 -
8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne
|
Phase 4 | |
Completed |
NCT00991198 -
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
|
Phase 2 |