Acne VulgarisNCT06141330
Vitamin D Supplementation in Acne
A study testing D Max Drops, Azithromycin 250 milligram Oral Capsule and Adapalene in people with Acne Vulgaris, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare in acne vulgaris patients. The main question it aims to answer is: To assess the therapeutic benefit of vitamin D supplement in acne vulgaris treatment, following a 2-month treatment regimen that includes vitamin D supplementation compared to conventional (systemic… Read more about this study
- Who is it for?
- Ages 13 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- D Max Drops, Azithromycin 250 milligram Oral Capsule and Adapalene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Feb 2024to 24 Aug 2025
- Phase
- Interventional
- 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 13 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Individuals aged between 13 and 40 years with diagnoses of Acne vulgaris are included.
Who cannot join
- Individuals currently undergoing treatment for polycystic ovary syndrome (PCOs)
- Those with obesity
- Individuals employing vitamin supplementation
- Those under the influence of topical or systemic steroids and acne treatment in the last 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Supplementation in Combination With Azithromycin and Topical Retinoid for Acne: A Randomized Controlled Trial
The goal of this clinical trial is to compare in acne vulgaris patients. The main question it aims to answer is:
- To assess the therapeutic benefit of vitamin D supplement in acne vulgaris treatment, following a 2-month treatment regimen that includes vitamin D supplementation compared to conventional (systemic azithromycin and topical retinoid) treatment alone.
Participants will receive vitamin D supplements in addition to capsule Azithromycin and topical retinoid.
Researchers will compare groups to determine efficacy of Vitamin D supplements in the treatment of Acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- D Max Drops, Azithromycin 250 milligram Oral Capsule, Adapalene
- Keywords
- AcneVulgaris, 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.
D Max DropsDietary supplement
Vitamin D
Azithromycin 250 milligram Oral CapsuleDrug
Anti Biotic
AdapaleneDrug
Retinoid
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Not described Receives: Dietary Supplement: D Max Drops; Drug: Azithromycin 250 milligram Oral Capsule; Drug: Adapalene |
| Placebo | Active comparator | Not described Receives: Drug: Azithromycin 250 milligram Oral Capsule; Drug: Adapalene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacious
Improvement in Global Acne Grading System Score from baseline to after 2 months of treatment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start24 Feb 2024
- Primary completion24 Feb 2025
- Study completion24 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- HITEC-Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqsa Naheed, HITEC-Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141330
- Sponsor's protocol ID
- Vit-D
- Status last verified
- May 2026
- First submitted
- 23 Oct 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not sharing
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation in Combination With Azithromycin and Topical Retinoid for Acne: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06141330
- Acronym / sponsor ID
- Vit-D
- Conditions
- Acne Vulgaris
- Keywords
- AcneVulgaris, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- HITEC-Institute of Medical SciencesUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Aug 2025 (actual)
- First posted
- 21 Nov 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.
The goal of this clinical trial is to compare in acne vulgaris patients. The main question it aims to answer is:
- To assess the therapeutic benefit of vitamin D supplement in acne vulgaris treatment, following a 2-month treatment regimen that includes vitamin D supplementation compared to conventional (systemic azithromycin and topical retinoid) treatment alone.
Participants will receive vitamin D supplements in addition to capsule Azithromycin and topical retinoid.
Researchers will compare groups to determine efficacy of Vitamin D supplements in the treatment of Acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: D Max Drops, Drug: Azithromycin 250 milligram Oral Capsule, Drug: Adapalene |
| Placebo | Active comparator | Drug: Azithromycin 250 milligram Oral Capsule, Drug: Adapalene |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Individuals aged between 13 and 40 years with diagnoses of Acne vulgaris are included.
Key exclusion criteria (4 listed)
- Individuals currently undergoing treatment for polycystic ovary syndrome (PCOs)
- Those with obesity
- Individuals employing vitamin supplementation
- Those under the influence of topical or systemic steroids and acne treatment in the last 2 months.
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 |
|---|---|---|
| D Max DropsVitamin D | Dietary supplement | Vitamin D |
| Azithromycin 250 milligram Oral CapsuleAnti Biotic | Drug | Placebo, Vitamin D |
| AdapaleneRetinoid | Drug | Placebo, Vitamin D |
Primary outcome
Efficacious
Time frame: 2 months
Improvement in Global Acne Grading System Score from baseline to after 2 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. not sharing
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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 study testing D Max Drops, Azithromycin 250 milligram Oral Capsule and Adapalene in people with Acne Vulgaris, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 19 May 2026. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacious (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026.