Acne VulgarisPhase 2NCT06252194
Comparative Study of Metformin Versus Doxycycline in Moderate to Severe Adult Acne Vulgaris Patients.
A Phase 2 study testing Metformin and doxycycline in people with Acne Vulgaris, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to compare the effect of doxycycline and metformin in treatment of acne vulgaris patients. The main question is aimed to answer is whether metformin is more effective than doxycycline in treatment of acne vulgaris patient or not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Metformin and doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBangladesh
- Study dates
- 5 Mar 2023to Mar 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed moderate and severe AV patients diagnosed by a dermatologist
- -
Who cannot join
- Patients receiving topical retinoids within last two months
- Pregnancy and lactation
- History of corticosteroids intake
- Suffering from malignancy or any cosmetic induced acne
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
BSMMU
Dhaka
registrar, 8512550, registrar@bsmmu.edu.bd
About this study
Official title: Comparative Study of Metformin Versus Doxycycline in Treatment of Moderate to Severe Adult Acne Vulgaris Patients: Multicentre, Randomized, Double-blind Trial.
The goal of this clinical trial is to compare the effect of doxycycline and metformin in treatment of acne vulgaris patients. The main question is aimed to answer is whether metformin is more effective than doxycycline in treatment of acne vulgaris patient or not.
Patients will be asked to take doxycycline along with tropical treatment in one group and metformin along with tropical treatment in another group.
Researcher will compare the clinical improvement in two groups.
- Conditions
- Acne Vulgaris
- Being tested
- Metformin and doxycycline
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin and doxycyclineDrug
Metformin 500 mg tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Metformin 500 mg twice daily along with topical retinoids for 12 weeks Receives: Drug: Metformin and doxycycline |
| Group B | Active comparator | Doxycycline 100 mg twice daily along with topical retinoids for 12 weeks Receives: Drug: Metformin and doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Acne Grading System (GAGS) Score
Acne Vulgaris Severity assesment by GAGS score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start5 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Muhammad Marnush, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252194
- Sponsor's protocol ID
- BSMMU/2022/11379
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Metformin Versus Doxycycline in Treatment of Moderate to Severe Adult Acne Vulgaris Patients: Multicentre, Randomized, Double-blind Trial.
- ClinicalTrials.gov ID
- NCT06252194
- Acronym / sponsor ID
- BSMMU/2022/11379
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 9 Feb 2024 (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 the effect of doxycycline and metformin in treatment of acne vulgaris patients. The main question is aimed to answer is whether metformin is more effective than doxycycline in treatment of acne vulgaris patient or not.
Patients will be asked to take doxycycline along with tropical treatment in one group and metformin along with tropical treatment in another group.
Researcher will compare the clinical improvement in two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Metformin and doxycyclineMetformin 500 mg twice daily along with topical retinoids for 12 weeks |
| Group B | Active comparator | Drug: Metformin and doxycyclineDoxycycline 100 mg twice daily along with topical retinoids for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed moderate and severe AV patients diagnosed by a dermatologist
- -
Key exclusion criteria (4 listed)
- Patients receiving topical retinoids within last two months
- Pregnancy and lactation
- History of corticosteroids intake
- Suffering from malignancy or any cosmetic induced acne
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 |
|---|---|---|
| Metformin and doxycyclineMetformin 500 mg tablet twice daily | Drug | Group A, Group B |
Primary outcome
Global Acne Grading System (GAGS) Score
Time frame: 12 weeks
Acne Vulgaris Severity assesment by GAGS score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin and doxycycline in people with Acne Vulgaris, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. 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 Bangladesh. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Muhammad Marnush, MBBS (88001714558447, marnushm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Acne Grading System (GAGS) Score (time frame: 12 weeks). 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 9 Feb 2024.