Acne VulgarisPhase 4NCT05096312

Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

A Phase 4 study testing Zinc gluconate and Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo] in people with Acne Vulgaris, run by East Avenue Medical Center, Philippines at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Acne Vulgaris is one of the most common dermatologic diagnoses requiring long-term maintenance therapy. Promising results of oral zinc gluconate in improving acne vulgaris has been described. Read more about this study

Who is it for?: Ages 18 to 27 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Zinc gluconate and Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 sitePhilippines
Study dates: 21 Dec 2018to 20 Jul 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 27 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Filipino patients, aged 18-27 years old
New patients diagnosed with Acne Vulgaris with a Global Acne Grading System score of at least 19
Able to read and write in English or Tagalog
Seen at the Dermatology out-patient clinic of East Avenue Medical Center

Who cannot join

Patients with other chronic dermatoses or systemic disease
Taking oral supplements or medications within the past 4 weeks
Patients who are pregnant or lactating

Trial locations and contacts

1 site in 1 country.

Philippines1 site

East Avenue Medical Center
Quezon City, National Capital Region

Other trials in Philippines

About this study

Official title: A Randomized, Double Blind, Placebo-Controlled Clinical Trial of the Effects of Oral Zinc Gluconate Among Diagnosed Acne Vulgaris Patients

Acne Vulgaris is one of the most common dermatologic diagnoses requiring long-term maintenance therapy. Promising results of oral zinc gluconate in improving acne vulgaris has been described.

A randomized, double blind, placebo-controlled clinical trial was utilized for this study with the objective to assess the efficacy of oral zinc gluconate in the improvement of disease activity in acne vulgaris patients as measured by the inflammatory score and Global Acne Grading System (GAGS) score.

Read the detailed description

Acne has four main pathogenic contributors: follicular hyperkeratinization, increased sebum production, Propionibacterium acnes (P. acnes) within the follicle, and inflammation. Treatment options for acne vulgaris include benzoyl peroxide, topical and oral retinoids, topical and oral antimicrobials, oral corticosteroids, and physical modalities such as acne surgery, laser and light therapy. Reports show that antibiotic resistance is a growing issue in the treatment regimen of acne vulgaris, making it less and less suitable for long-term treatment, hence other options that can be substitutes or adjuncts to treatment may be useful in this condition. For long-term or maintenance therapy, physicians should consider effectivity, cost, and adverse effects. Several studies have explored the effect of oral zinc on acne vulgaris. Since zinc is more cost-effective and has less adverse effects compared to most antibiotics, this may prove helpful for the Filipino patient in terms of safety and economy for long-term therapy.

The aim of this study is to assess the efficacy of oral zinc gluconate in the improvement of disease activity in acne vulgaris patients, to determine the demographic and clinical profile of Acne Vulgaris patients, to determine the disease activity measured by the inflammatory score and GAGS score of acne vulgaris patients on initial consult, at 4 weeks, and at 8 weeks, and to determine if there is a significant difference in disease activity as measured by the inflammatory score and GAGS score among acne vulgaris patients given placebo and oral zinc gluconate.

A randomized, double blind, placebo-controlled clinical trial was utilized. Adults with moderate to severe acne vulgaris were included in the study. Patients were evaluated using the inflammatory score and Global Acne Grading System (GAGS) at the start, at midpoint, and at the end of the trial. One group of participants received zinc gluconate supplementation and another group received placebo for 60 days. All participants received topical adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening. Improvement in acne severity was then determined and compared.

Conditions: Acne Vulgaris
Being tested: Zinc gluconate, Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo], Placebo
Keywords: acne vulgaris, zinc gluconate, inflammation, adapalene, benzoyl peroxide, Global Acne Grading System
Medical subject headings: Acne Vulgaris, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zinc gluconateDietary supplement
Also called Solgar zinc gluconate
oral zinc gluconate 200mg
Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]Drug
Also called Epiduo Forte
Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening
PlaceboOther
contains cornstarch

Study groups in NCT05096312
Study group	Role	What they receive
Zinc gluconate group	Active comparator	interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days. Receives: Dietary Supplement: Zinc gluconate; Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]
Placebo group	Placebo comparator	interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days. Receives: Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Global Acne Grading System Score
changes in Global Acne Grading System (GAGS) score. Minimum score is 0, maximum score is 44. Cut off scores are as follows: no lesion (0), mild (1-18), moderate (19-30), severe (31-38), and very severe (≥39)
Measured: upon enrollment, at 4 weeks, at 8 weeks
Inflammatory Score
changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation.
Measured: upon enrollment, at 4 weeks, at 8 weeks

Secondary outcomes (2)

Examiner's Assessment Score
examiner's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (≥50%)
Measured: at 8 weeks
Patient's Self-assessment Score
patient's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (≥50%)
Measured: at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 201820 Jul 2019

First posted27 Oct 2021
Study start21 Dec 2018
Primary completion19 Jul 2019
Study completion20 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (32)Papers the sponsor has linked to this study.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05096312
Sponsor's protocol ID: EAMC IERB 2018-52
Status last verified: Apr 2022
First submitted: 14 Oct 2021
Last updated: 11 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013 Mar;168(3):474-85. doi: 10.1111/bjd.12149.
PubMed 23210645
Humphrey S. Antibiotic resistance in acne treatment. Skin Therapy Lett. 2012 Oct;17(9):1-3.
PubMed 23032935
Tan JK, Bhate K. A global perspective on the epidemiology of acne. Br J Dermatol. 2015 Jul;172 Suppl 1:3-12. doi: 10.1111/bjd.13462.
PubMed 25597339
Collier CN, Harper JC, Cafardi JA, Cantrell WC, Wang W, Foster KW, Elewski BE. The prevalence of acne in adults 20 years and older. J Am Acad Dermatol. 2008 Jan;58(1):56-9. doi: 10.1016/j.jaad.2007.06.045. Epub 2007 Oct 22.
PubMed 17945383
Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80.
PubMed 10495379
Thiboutot DM, Dreno B, Abanmi A, Alexis AF, Araviiskaia E, Barona Cabal MI, Bettoli V, Casintahan F, Chow S, da Costa A, El Ouazzani T, Goh CL, Gollnick HPM, Gomez M, Hayashi N, Herane MI, Honeyman J, Kang S, Kemeny L, Kubba R, Lambert J, Layton AM, Leyden JJ, Lopez-Estebaranz JL, Noppakun N, Ochsendorf F, Oprica C, Orozco B, Perez M, Piquero-Martin J, See JA, Suh DH, Tan J, Lozada VT, Troielli P, Xiang LF. Practical management of acne for clinicians: An international consensus from the Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2018 Feb;78(2 Suppl 1):S1-S23.e1. doi: 10.1016/j.jaad.2017.09.078. Epub 2017 Nov 8.
PubMed 29127053
Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4.
PubMed 26945741
Al-Shobaili HA. Oxidants and anti-oxidants status in acne vulgaris patients with varying severity. Ann Clin Lab Sci. 2014 Spring;44(2):202-7.
PubMed 24795060
Bray TM, Bettger WJ. The physiological role of zinc as an antioxidant. Free Radic Biol Med. 1990;8(3):281-91. doi: 10.1016/0891-5849(90)90076-u.
PubMed 2187766
Prasad AS. Zinc is an Antioxidant and Anti-Inflammatory Agent: Its Role in Human Health. Front Nutr. 2014 Sep 1;1:14. doi: 10.3389/fnut.2014.00014. eCollection 2014.
PubMed 25988117
Rostan EF, DeBuys HV, Madey DL, Pinnell SR. Evidence supporting zinc as an important antioxidant for skin. Int J Dermatol. 2002 Sep;41(9):606-11. doi: 10.1046/j.1365-4362.2002.01567.x.
PubMed 12358835
Sardana K, Chugh S, Garg VK. The role of zinc in acne and prevention of resistance: have we missed the "base" effect? Int J Dermatol. 2014 Jan;53(1):125-7. doi: 10.1111/ijd.12264. No abstract available.
PubMed 24350859
Buxaderas SC, Farre-Rovira R. Whole blood and serum zinc levels in relation to sex and age. Rev Esp Fisiol. 1985 Dec;41(4):463-70.
PubMed 4095368
Amer M, Bahgat MR, Tosson Z, Abdel Mowla MY, Amer K. Serum zinc in acne vulgaris. Int J Dermatol. 1982 Oct;21(8):481-4. doi: 10.1111/j.1365-4362.1982.tb03188.x.
PubMed 6217164
Arora PN, Dhillon KS, Rajan SR, Sayal SK, Das AL. Serum Zinc Levels in Cutaneous Disorders. Med J Armed Forces India. 2002 Oct;58(4):304-6. doi: 10.1016/S0377-1237(02)80083-1. Epub 2011 Jul 21.
PubMed 27407419

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo-Controlled Clinical Trial of the Effects of Oral Zinc Gluconate Among Diagnosed Acne Vulgaris Patients
ClinicalTrials.gov ID: NCT05096312
Acronym / sponsor ID: EAMC IERB 2018-52
Conditions: Acne Vulgaris
Keywords: acne vulgaris, zinc gluconate, inflammation, adapalene, benzoyl peroxide, Global Acne Grading System
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: East Avenue Medical Center, PhilippinesOther government
Study start: 21 Dec 2018 (actual)
Primary completion: 19 Jul 2019 (actual)
Study completion: 20 Jul 2019 (actual)
First posted: 27 Oct 2021 (actual)
Results: Posted 13 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Acne Vulgaris is one of the most common dermatologic diagnoses requiring long-term maintenance therapy. Promising results of oral zinc gluconate in improving acne vulgaris has been described.

Detailed description

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
Zinc gluconate group	Active comparator	Dietary Supplement: Zinc gluconate, Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.
Placebo group	Placebo comparator	Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo], Other: Placebointerventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.

Who may qualify

Ages: 18 to 27 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Filipino patients, aged 18-27 years old
New patients diagnosed with Acne Vulgaris with a Global Acne Grading System score of at least 19
Able to read and write in English or Tagalog
Seen at the Dermatology out-patient clinic of East Avenue Medical Center

Key exclusion criteria (3 listed)

Patients with other chronic dermatoses or systemic disease
Taking oral supplements or medications within the past 4 weeks
Patients who are pregnant or lactating

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 gluconateAlso: Solgar zinc gluconateoral zinc gluconate 200mg	Dietary supplement	Zinc gluconate group
Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]Also: Epiduo ForteAdapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening	Drug	Placebo group, Zinc gluconate group
Placebocontains cornstarch	Other	Placebo group

Primary outcome

Global Acne Grading System Score
Time frame: upon enrollment, at 4 weeks, at 8 weeks
changes in Global Acne Grading System (GAGS) score. Minimum score is 0, maximum score is 44. Cut off scores are as follows: no lesion (0), mild (1-18), moderate (19-30), severe (31-38), and very severe (≥39)
Inflammatory Score
Time frame: upon enrollment, at 4 weeks, at 8 weeks
changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation.

2 secondary outcomes

Examiner's Assessment Score
Time frame: at 8 weeks
Patient's Self-assessment Score
Time frame: at 8 weeks

Results and safety

Results posted to the registry on 13 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zinc Gluconate Group	11	8
Placebo Group	12	8

Primary outcome: Global Acne Grading System Score

Time frame: upon enrollment, at 4 weeks, at 8 weeks. Median (Full Range). Unit: score on a scale

Measure	Zinc Gluconate Group n = 8	Placebo Group n = 8
Initial	32 (25.67 to 43)	30.33 (21 to 38.33)
4 weeks	21.67 (19 to 29)	27.5 (11 to 36)
8 weeks	14.34 (2 to 24.67)	21.67 (7.67 to 27.67)

Population analysed: the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.

Primary outcome: Inflammatory Score

Time frame: upon enrollment, at 4 weeks, at 8 weeks. Median (Full Range). Unit: score on a scale

Measure	Zinc Gluconate Group n = 8	Placebo Group n = 8
Initial	70 (43 to 110.67)	48.5 (19.67 to 72.33)
4 weeks	22.67 (12.67 to 42.38)	47.5 (10.67 to 73.67)
8 weeks	8.34 (3 to 32.33)	22.67 (10.67 to 51)

Population analysed: the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zinc Gluconate Group	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Placebo Group	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23210645Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013 Mar;168(3):474-85. doi: 10.1111/bjd.12149.
Background: PubMed 23032935Humphrey S. Antibiotic resistance in acne treatment. Skin Therapy Lett. 2012 Oct;17(9):1-3.
Background: PubMed 25597339Tan JK, Bhate K. A global perspective on the epidemiology of acne. Br J Dermatol. 2015 Jul;172 Suppl 1:3-12. doi: 10.1111/bjd.13462.
Background: PubMed 17945383Collier CN, Harper JC, Cafardi JA, Cantrell WC, Wang W, Foster KW, Elewski BE. The prevalence of acne in adults 20 years and older. J Am Acad Dermatol. 2008 Jan;58(1):56-9. doi: 10.1016/j.jaad.2007.06.045. Epub 2007 Oct 22.
Background: PubMed 10495379Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80.
Background: PubMed 29127053Thiboutot DM, Dreno B, Abanmi A, Alexis AF, Araviiskaia E, Barona Cabal MI, Bettoli V, Casintahan F, Chow S, da Costa A, El Ouazzani T, Goh CL, Gollnick HPM, Gomez M, Hayashi N, Herane MI, Honeyman J, Kang S, Kemeny L, Kubba R, Lambert J, Layton AM, Leyden JJ, Lopez-Estebaranz JL, Noppakun N, Ochsendorf F, Oprica C, Orozco B, Perez M, Piquero-Martin J, See JA, Suh DH, Tan J, Lozada VT, Troielli P, Xiang LF. Practical management of acne for clinicians: An international consensus from the Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2018 Feb;78(2 Suppl 1):S1-S23.e1. doi: 10.1016/j.jaad.2017.09.078. Epub 2017 Nov 8.
Background: PubMed 26945741Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4.
Background: PubMed 24795060Al-Shobaili HA. Oxidants and anti-oxidants status in acne vulgaris patients with varying severity. Ann Clin Lab Sci. 2014 Spring;44(2):202-7.
Background: PubMed 2187766Bray TM, Bettger WJ. The physiological role of zinc as an antioxidant. Free Radic Biol Med. 1990;8(3):281-91. doi: 10.1016/0891-5849(90)90076-u.
Background: PubMed 25988117Prasad AS. Zinc is an Antioxidant and Anti-Inflammatory Agent: Its Role in Human Health. Front Nutr. 2014 Sep 1;1:14. doi: 10.3389/fnut.2014.00014. eCollection 2014.
Background: PubMed 12358835Rostan EF, DeBuys HV, Madey DL, Pinnell SR. Evidence supporting zinc as an important antioxidant for skin. Int J Dermatol. 2002 Sep;41(9):606-11. doi: 10.1046/j.1365-4362.2002.01567.x.
Background: PubMed 24350859Sardana K, Chugh S, Garg VK. The role of zinc in acne and prevention of resistance: have we missed the "base" effect? Int J Dermatol. 2014 Jan;53(1):125-7. doi: 10.1111/ijd.12264. No abstract available.
NIH Zinc fact sheetLink provided by the sponsor.
Zinc for testosteroneLink provided by the sponsor.
Serum Trace Elements (Zinc, Copper and Magnesium) Status in Iraqi Patients with Acne Vulgaris: (Case- Controlled Study)Link provided by the sponsor.
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.

Monique Lianne C. Lim-Ang, MD,MBA,DPDS principal investigator

East Avenue Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 11 May 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 Philippines. 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?

Yes. Results are posted in the registry (first posted 13 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Global Acne Grading System Score (time frame: upon enrollment, at 4 weeks, at 8 weeks). The study lists 2 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 NCT05096312, which also lists 32 linked publications.

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 11 May 2022.