Acne VulgarisPhase 2NCT04899843
Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients
A Phase 2 study testing Zinc sulphate tablet 20 mg in people with Acne Vulgaris, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
The study was 8 weeks, randomized, double-blind, placebo-controlled trial to assess the effect of zinc sulphate on symptoms of mild and moderate acne vulgaris in 122 patients. Participants was assessed at baseline, and 8 weeks. Read more about this study
- Who is it for?
- Ages 11 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Zinc sulphate tablet 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteBangladesh
- Study dates
- 27 Apr 2021to 30 Nov 2021
- 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 11 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed mild and moderate AV patients diagnosed by a dermatologist at the outpatient Department of Dermatology and Venereology,
- Age: 11-35 years,
- Gender: Both male and female
Who cannot join
- Pregnancy and lactation,
- History of oral contraceptive pills, zinc, and iron intake,
- Suffering from any cosmetic induced acne
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients: A Randomized, Double-Blind, Placebo-Controlled Trial
The study was 8 weeks, randomized, double-blind, placebo-controlled trial to assess the effect of zinc sulphate on symptoms of mild and moderate acne vulgaris in 122 patients. Participants was assessed at baseline, and 8 weeks. Subjects was randomized to receive either 20 mg elemental zinc daily or 20 mg placebo tablet daily for 8 weeks. The primary outcome was the measure of the GAGS score and the secondary measure includes serum zinc level and evaluate adverse effects.
Read the detailed description
Acne vulgaris (AV) is the eighth most prevalent disease worldwide. Acne is a self-limiting condition, it may cause significant psychological and social problems, depression, disfigurement, and scarring that can persist for a lifetime. Multiple factors contribute to acne pathogenesis including increased sebum production, aberrant keratinization of the pilosebaceous duct, bacteria such as Propionibacterium acnes, hormonal influences, the skin microbiome, and chronic inflammation. Relapse rates in patients with acne after treatment with standard of care vary between 10% and 60%. Recent trials attempted to assess the effect of zinc in reducing the severity of symptoms of acne vulgaris patients. This study evaluates whether there is any role of zinc in reducing acne symptoms between those who did and did not receive zinc in an 8 weeks period. This includes 122 acne vulgaris patients who were recruited from Dermatology and Venereology OPD of BSMMU. Participants took either 20 mg elemental zinc daily in the form of zinc sulphate tablet or 20 mg placebo tablet daily for 8 weeks. Initially, baseline serum zinc level was measured and repeated again after 8 weeks of intervention. A baseline acne symptoms survey was done by GAGS score and also repeated at 8 weeks.
- Conditions
- Acne Vulgaris
- Being tested
- Zinc sulphate tablet 20 mg, Placebo tablet 20 mg
- Keywords
- AV Zinc GAGS Serum zinc level
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc sulphate tablet 20 mgDietary supplement
Zinc sulphate tablet 20 mg daily orally for 8 weeks along with topical retinoids.
Placebo tablet 20 mgDietary supplement
Placebo tablet 20 mg daily orally for 8 weeks along with topical retinoids
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | This arm includes 61 acne vulgaris patients receiving topical retinoids Receives: Dietary Supplement: Zinc sulphate tablet 20 mg |
| Control | Placebo comparator | This arm includes 61 acne vulgaris patients receiving topical retinoids Receives: Dietary Supplement: Placebo tablet 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne vulgaris severity score assessment
Assess the severity score of acne vulgaris symptoms by GAGS(Global Acne Grading System) at baseline, and after 8 weeks.
And compare the score between two groups. GAGS scores : 1-18 Mild, 19-30 Moderate
Measured: 8 weeks
Secondary outcomes (1)
Biochemical assessment and evaluate the adverse effects
Serum zinc level was assessed at baseline and after 8 weeks intervention.Compare the serum zinc level between two group. Adverse effects are evaluated which reported by patients.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start27 Apr 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
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
- Model description
- Newly diagnosed Acne vulgaris patients
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Humayra Rumu, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Prof. Md. Sayedur Rahman, MBBS, Mphil, FCPS, Study chair, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899843
- Sponsor's protocol ID
- BSMMU/2021/3959
- Status last verified
- Mar 2022
- First submitted
- 11 May 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04899843
- Acronym / sponsor ID
- BSMMU/2021/3959
- Conditions
- Acne Vulgaris
- Keywords
- AV Zinc GAGS Serum zinc level
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 25 May 2021 (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 study was 8 weeks, randomized, double-blind, placebo-controlled trial to assess the effect of zinc sulphate on symptoms of mild and moderate acne vulgaris in 122 patients. Participants was assessed at baseline, and 8 weeks. Subjects was randomized to receive either 20 mg elemental zinc daily or 20 mg placebo tablet daily for 8 weeks. The primary outcome was the measure of the GAGS score and the secondary measure includes serum zinc level and evaluate adverse effects.
Detailed description
Acne vulgaris (AV) is the eighth most prevalent disease worldwide. Acne is a self-limiting condition, it may cause significant psychological and social problems, depression, disfigurement, and scarring that can persist for a lifetime. Multiple factors contribute to acne pathogenesis including increased sebum production, aberrant keratinization of the pilosebaceous duct, bacteria such as Propionibacterium acnes, hormonal influences, the skin microbiome, and chronic inflammation. Relapse rates in patients with acne after treatment with standard of care vary between 10% and 60%. Recent trials attempted to assess the effect of zinc in reducing the severity of symptoms of acne vulgaris patients. This study evaluates whether there is any role of zinc in reducing acne symptoms between those who did and did not receive zinc in an 8 weeks period. This includes 122 acne vulgaris patients who were recruited from Dermatology and Venereology OPD of BSMMU. Participants took either 20 mg elemental zinc daily in the form of zinc sulphate tablet or 20 mg placebo tablet daily for 8 weeks. Initially, baseline serum zinc level was measured and repeated again after 8 weeks of intervention. A baseline acne symptoms survey was done by GAGS score and also repeated at 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Newly diagnosed Acne vulgaris patients
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Dietary Supplement: Zinc sulphate tablet 20 mgThis arm includes 61 acne vulgaris patients receiving topical retinoids |
| Control | Placebo comparator | Dietary Supplement: Placebo tablet 20 mgThis arm includes 61 acne vulgaris patients receiving topical retinoids |
Who may qualify
- Ages
- 11 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Newly diagnosed mild and moderate AV patients diagnosed by a dermatologist at the outpatient Department of Dermatology and Venereology,
- Age: 11-35 years,
- Gender: Both male and female
Key exclusion criteria (3 listed)
- Pregnancy and lactation,
- History of oral contraceptive pills, zinc, and iron intake,
- Suffering from 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 |
|---|---|---|
| Zinc sulphate tablet 20 mgZinc sulphate tablet 20 mg daily orally for 8 weeks along with topical retinoids. | Dietary supplement | Experimental |
| Placebo tablet 20 mgPlacebo tablet 20 mg daily orally for 8 weeks along with topical retinoids | Dietary supplement | Control |
Primary outcome
Acne vulgaris severity score assessment
Time frame: 8 weeks
Assess the severity score of acne vulgaris symptoms by GAGS(Global Acne Grading System) at baseline, and after 8 weeks. And compare the score between two groups. GAGS scores : 1-18 Mild, 19-30 Moderate
1 secondary outcome
Biochemical assessment and evaluate the adverse effects
Time frame: 8 weeks
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 21 Mar 2022.
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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.
Prof. Md. Sayedur Rahman, MBBS, Mphil, FCPS study chair
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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 Zinc sulphate tablet 20 mg 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 3 inclusion and 3 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 21 Mar 2022. 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. 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 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?
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?
Acne vulgaris severity score assessment (time frame: 8 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 21 Mar 2022.