Acne VulgarisPhase 4NCT05758259
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
A Phase 4 study testing combination oral and topical vitamin D in people with Acne Vulgaris and Vitamin D, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acne Vulgaris, Vitamin D
- What is being tested?
- combination oral and topical vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Feb 2023to Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 1358
About this study
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.
Read more
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
- Being tested
- combination oral and topical vitamin D, oral placebo and topical cholecalciferol, oral placebo and basic ingredient placebo topical vitamin D
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination oral and topical vitamin DDrug
combination vitamin D 2000 IU 1x1 and topical 7-Dehydrocholesterol 5000 mcg 2x1
oral placebo and topical cholecalciferolDrug
oral placebo and topical 7-Dehydrocholesterol 5000 mcg 2x1
oral placebo and basic ingredient placebo topical vitamin DDrug
oral placebo and basic ingredient placebo topical vitamin D similar to the ointment
| Study group | Role | What they receive |
|---|---|---|
| combination vitamin D oral and topical cholecalciferol | Experimental | 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 Receives: Drug: combination oral and topical vitamin D |
| oral placebo and topical vitamin D | Active comparator | 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 Receives: Drug: oral placebo and topical cholecalciferol |
| oral placebo and basic ingredient placebo topical vitamin D | Placebo comparator | 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 Receives: Drug: oral placebo and basic ingredient placebo topical vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Changes in counts of inflammation and non-inflammation lesions (assessed in week 8th)
Measured: baseline and week 8th
Existence in VDR expression on acne lesion
VDR count on CD 45 flowcytometry
Measured: baseline
Changes from baseline in IL-1β expression on acne lesion
IL-1β expression in pg/mL
Measured: baseline and week 8th
Changes from baseline in IL-6 expression on acne lesion
IL-6 expression in pg/mL
Measured: baseline and week 8th
Changes from baseline in IL-10 expression on acne lesion
IL-10 expression in pg/mL
Measured: baseline and week 8th
Changes from baseline in IL-17 expression on acne lesion
IL-17 expression in pg/mL
Measured: baseline and week 8th
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start16 Feb 2023
- Primary completionAug 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Nelly Herfina Dahlan Sp.KK, M.Kes, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758259
- Sponsor's protocol ID
- KET-922/2022
- Status last verified
- Mar 2023
- First submitted
- 8 Jan 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dahlan NH, Sitohang IBS, Indriatmi W, Wibowo H, Enggy LE. Correlation Between Reduced IL-1beta Levels in Acne Lesions and the Decrease in Acne Inflammatory Lesions Following Topical Vitamin D Administration: A Double-Blind Randomized Controlled Trial. Clin Cosmet Investig Dermatol. 2024 Oct 1;17:2183-2195. doi: 10.2147/CCID.S475068. eCollection 2024.
PubMed 39372262
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05758259
- Acronym / sponsor ID
- KET-922/2022
- Conditions
- Acne Vulgaris, Vitamin D
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combination vitamin D oral and topical cholecalciferol | Experimental | Drug: combination oral and topical vitamin Dcombination 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 | Active comparator | Drug: oral placebo and topical cholecalciferoloral 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 |
| oral placebo and basic ingredient placebo topical vitamin D | Placebo comparator | Drug: oral placebo and basic ingredient placebo topical vitamin DDaily 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination oral and topical vitamin Dcombination vitamin D 2000 IU 1x1 and topical 7-Dehydrocholesterol 5000 mcg 2x1 | Drug | combination vitamin D oral and topical cholecalciferol |
| oral placebo and topical cholecalciferoloral placebo and topical 7-Dehydrocholesterol 5000 mcg 2x1 | Drug | oral placebo and topical vitamin D |
| oral placebo and basic ingredient placebo topical vitamin Doral placebo and basic ingredient placebo topical vitamin D similar to the ointment | Drug | oral placebo and basic ingredient placebo topical vitamin D |
Primary outcome
Clinical improvement
Time frame: baseline and week 8th
Changes in counts of inflammation and non-inflammation lesions (assessed in week 8th)
Existence in VDR expression on acne lesion
Time frame: baseline
VDR count on CD 45 flowcytometry
Changes from baseline in IL-1β expression on acne lesion
Time frame: baseline and week 8th
IL-1β expression in pg/mL
Changes from baseline in IL-6 expression on acne lesion
Time frame: baseline and week 8th
IL-6 expression in pg/mL
Changes from baseline in IL-10 expression on acne lesion
Time frame: baseline and week 8th
IL-10 expression in pg/mL
Changes from baseline in IL-17 expression on acne lesion
Time frame: baseline and week 8th
IL-17 expression in pg/mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 39372262Dahlan NH, Sitohang IBS, Indriatmi W, Wibowo H, Enggy LE. Correlation Between Reduced IL-1beta Levels in Acne Lesions and the Decrease in Acne Inflammatory Lesions Following Topical Vitamin D Administration: A Double-Blind Randomized Controlled Trial. Clin Cosmet Investig Dermatol. 2024 Oct 1;17:2183-2195. doi: 10.2147/CCID.S475068. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing combination oral and topical vitamin D in people with Acne Vulgaris and Vitamin D, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: baseline and week 8th). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05758259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.