Acne VulgarisPhase 4METROCLINNCT07392047
Metronidazole 2% Gel Versus Clindamycin 1% Gel for Moderate Acne Vulgaris
A Phase 4 study testing Metronidazole Topical Gel 2% and Clindamycin Topical Gel 1% in people with Acne Vulgaris, run by Jinnah Postgraduate Medical Centre.
Trial summary
Acne vulgaris is a common inflammatory skin disorder. This randomized controlled trial (RCT) will compare the efficacy and safety of 2% metronidazole gel versus 1% clindamycin gel in adults with moderate acne vulgaris at Jinnah Postgraduate Medical Centre (JPMC), Karachi. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Metronidazole Topical Gel 2% and Clindamycin Topical Gel 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-35 years of either sex.
- Clinical diagnosis of moderate acne vulgaris, defined as a Modified Global Acne Grading System (mGAGS) score of 45-80.
- Not currently using any other anti-acne treatment (topical or systemic).
Who cannot join
- Pregnant or lactating women.
- Severe acne vulgaris, defined as an mGAGS score >80.
- Known hypersensitivity/allergy to metronidazole or clindamycin (or any component of the study gels).
- Any other dermatologic condition affecting the face that may interfere with assessment of acne severity or treatment response.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Of The Efficacy Of 2% Metronidazole Gel Versus 1% Clindamycin Gel In The Treatment Of Moderate Acne Vulgaris
Acne vulgaris is a common inflammatory skin disorder. This randomized controlled trial (RCT) will compare the efficacy and safety of 2% metronidazole gel versus 1% clindamycin gel in adults with moderate acne vulgaris at Jinnah Postgraduate Medical Centre (JPMC), Karachi. Sixty eligible participants (18-35 years) will be enrolled using consecutive sampling and randomized in a 1:1 ratio using blocked randomization. Participants will apply the assigned gel as a thin layer twice daily for 12 weeks. Acne severity will be assessed using the Modified Global Acne Grading System (mGAGS) at baseline and at weeks 4, 8, and 12. The primary outcome is the proportion of participants achieving at least a 50% reduction from baseline in total mGAGS score at week 12. Local adverse effects (e.g., erythema, itching, irritation) will be recorded at each follow-up visit.
Read the detailed description
This is an investigator-initiated, parallel-group randomized controlled trial (RCT) conducted in the Department of Dermatology, Jinnah Postgraduate Medical Centre (JPMC), Karachi. After approval from the Institutional Review Board (IRB) and the College of Physicians and Surgeons Pakistan (CPSP), adults aged 18-35 years with moderate acne vulgaris, defined by a Modified Global Acne Grading System (mGAGS) score of 45-80, and not using other anti-acne therapies will be enrolled using non-probability consecutive sampling. Participants who are pregnant or lactating, have severe acne (mGAGS >80), have a known allergy to metronidazole or clindamycin, or have other dermatologic conditions affecting the face will be excluded.
Participants will be randomized in a 1:1 allocation using blocked randomization to receive either metronidazole 2% gel or clindamycin 1% gel. The assigned treatment will be applied as a thin layer twice daily (morning and night) for 12 weeks after gentle cleansing and drying of the face. Concomitant anti-acne products will be discouraged during the intervention period. Follow-up assessments will occur at weeks 4, 8, and 12. At each visit, acne severity will be assessed using mGAGS, and tolerability will be evaluated by recording local adverse effects, including erythema, itching, dryness, burning, or irritation.
The primary endpoint is treatment response at week 12, defined as a ≥50% reduction in total mGAGS score from baseline. Participants will be classified as responders (≥50% reduction) or non-responders (<50% reduction). Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Categorical outcomes will be compared using the chi-square test or Fisher's exact test, and continuous variables will be compared using the independent-samples t test or Mann-Whitney U test according to data distribution. Stratified analyses will explore effect modification by age and sex. A two-sided p value ≤0.05 will be considered statistically significant.
- Conditions
- Acne Vulgaris
- Being tested
- Metronidazole Topical Gel 2%, Clindamycin Topical Gel 1%
- Keywords
- Moderate acne, Metronidazole gel, Clindamycin gel, Topical antibiotic, Modified Global Acne Grading System
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole Topical Gel 2%Drug
Topical metronidazole gel 2% applied as a thin layer to affected areas twice daily (morning and night) for 12 weeks after gentle cleansing and drying.
Clindamycin Topical Gel 1%Drug
Topical clindamycin gel 1% applied as a thin layer to affected areas twice daily (morning and night) for 12 weeks after gentle cleansing and drying.
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole 2% Gel | Experimental | Participants will apply 2% metronidazole gel as a thin layer twice daily (morning and night) for 12 weeks after gentle cleansing and drying. Receives: Drug: Metronidazole Topical Gel 2% |
| Clindamycin 1% Gel | Active comparator | Participants will apply 1% clindamycin gel as a thin layer twice daily (morning and night) for 12 weeks after gentle cleansing and drying. Receives: Drug: Clindamycin Topical Gel 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response by mGAGS at Week 12
Proportion of participants achieving ≥50% reduction in total Modified Global Acne Grading System (mGAGS) score from baseline (Responder = Yes; Non-responder = No).
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 posted6 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- Model description
- Parallel-group, two-arm randomized controlled trial. Eligible participants with moderate acne vulgaris will be randomized in a 1:1 ratio using blocked randomization to receive either 2% metronidazole gel or 1% clindamycin gel, applied twice daily for 12 weeks, with follow-up assessments at weeks 4, 8, and 12.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rubab Murtaza, Jinnah Postgraduate Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392047
- Sponsor's protocol ID
- JPMC-ACNE-RCT-01
- Acronym
- METROCLIN
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared outside the study team. Data will be stored securely at the study site and used only for the purposes described in the protocol. Aggregate, de-identified results will be reported in publications
Publications
20. Verma R, Yadav P, Chudhari M, Patel J, Umrigar D. Comparison of efficacy of two topical drug therapy of acne vulgaris-1% clindamycin versus 5% dapsone: a split-face comparative study. Natl J Physiol Pharm Pharmacol. 2022;12(6):817-822.
Irshad M, Syed AW, Shahid MW, Naeem U, Mirza M, Naeem S. Comparative Effects of Azithromycin and Probiotics for Treatment of Acne Vulgaris. J Coll Physicians Surg Pak. 2023 May;33(5):516-520. doi: 10.29271/jcpsp.2023.05.516.
PubMed 37190684Naveed S, Masood S, Rahman A, Awan S, Tabassum S. Impact of acne on quality of life in young Pakistani adults and its relationship with severity: A multicenter study. Pak J Med Sci. 2021 May-Jun;37(3):727-732. doi: 10.12669/pjms.37.3.2819.
PubMed 34104156Dessinioti C, Katsambas A. Antibiotics and Antimicrobial Resistance in Acne: Epidemiological Trends and Clinical Practice Considerations. Yale J Biol Med. 2022 Dec 22;95(4):429-443. eCollection 2022 Dec.
PubMed 36568833Dreno B, Dekio I, Baldwin H, Demessant AL, Dagnelie MA, Khammari A, Corvec S. Acne microbiome: From phyla to phylotypes. J Eur Acad Dermatol Venereol. 2024 Apr;38(4):657-664. doi: 10.1111/jdv.19540. Epub 2023 Oct 11.
PubMed 3777734315. Chen X, et al. Metronidazole: the clinical efficacy and pharmacological effects. Biomedicines. 2023;11(8):2153. doi:10.3390/biomedicines11082153
Khodaeiani E, Fouladi RF, Yousefi N, Amirnia M, Babaeinejad S, Shokri J. Efficacy of 2% metronidazole gel in moderate acne vulgaris. Indian J Dermatol. 2012 Jul;57(4):279-81. doi: 10.4103/0019-5154.97666.
PubMed 22837561Nakase K, Aoki S, Sei S, Fukumoto S, Horiuchi Y, Yasuda T, Tanioka M, Sugai J, Huh WW, Kakuta M, Nomoto M, Shimada T, Watanabe M, Kobayashi M, Murakami S, Takeo C, Tsubouchi R, Hayashi N, Noguchi N. Characterization of acne patients carrying clindamycin-resistant Cutibacterium acnes: A Japanese multicenter study. J Dermatol. 2020 Aug;47(8):863-869. doi: 10.1111/1346-8138.15397. Epub 2020 May 18.
PubMed 32424832Aoki S, Nakase K, Nakaminami H, Wajima T, Hayashi N, Noguchi N. Transferable Multidrug-Resistance Plasmid Carrying a Novel Macrolide-Clindamycin Resistance Gene, erm(50), in Cutibacterium acnes. Antimicrob Agents Chemother. 2020 Feb 21;64(3):e01810-19. doi: 10.1128/AAC.01810-19. Print 2020 Feb 21.
PubMed 31844016Koyanagi S, Koizumi J, Nakase K, Hayashi N, Horiuchi Y, Watanabe K, Asai T, Yamazaki A, Nakazaki E, Nakaminami H. Increased frequency of clindamycin-resistant Cutibacterium acnes strains isolated from Japanese patients with acne vulgaris caused by the prevalence of exogenous resistance genes. J Dermatol. 2023 Jun;50(6):793-799. doi: 10.1111/1346-8138.16757. Epub 2023 Mar 7.
PubMed 3688029510. Beig M, et al. Prevalence of antibiotic-resistant Cutibacterium acnes isolated from acne patients: a systematic review and meta-analysis. Lancet Reg Health Southeast Asia. 2024. doi:10.1016/j.lansea.2024.100137
Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, Desai SR, Druby KM, Freeman EE, Keri JE, Stein Gold LF, Tan JKL, Tollefson MM, Weiss JS, Wu PA, Zaenglein AL, Han JM, Barbieri JS. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024 May;90(5):1006.e1-1006.e30. doi: 10.1016/j.jaad.2023.12.017. Epub 2024 Jan 30.
PubMed 383001707. Verma R, Yadav P, Chudhari M, Patel J, Umrigar D. Comparison of efficacy of two topical drug therapy of acne vulgaris - 1% clindamycin versus 5% dapsone: A split face comparative study. Natl J Physiol Pharm Pharmacol. 2022;12(6):817-22
6. Rahim S, Kumar A. The impact of acne vulgaris on quality of life and psychic health in young adolescents of Rehman Medical College, Peshawar, Pakistan: a cross-sectional study. J Rehman Med Inst. 2024;8(1):1-5.
Babar O, Mobeen A. Prevalence and Psychological Impact of Acne Vulgaris in Female Undergraduate Medical Students of Rawalpindi and Islamabad, Pakistan. Cureus. 2019 Sep 22;11(9):e5722. doi: 10.7759/cureus.5722.
PubMed 31720190
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Efficacy Of 2% Metronidazole Gel Versus 1% Clindamycin Gel In The Treatment Of Moderate Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07392047
- Acronym / sponsor ID
- METROCLIN / JPMC-ACNE-RCT-01
- Conditions
- Acne Vulgaris
- Keywords
- Moderate acne, Metronidazole gel, Clindamycin gel, Topical antibiotic, Modified Global Acne Grading System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 6 Feb 2026 (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.
Acne vulgaris is a common inflammatory skin disorder. This randomized controlled trial (RCT) will compare the efficacy and safety of 2% metronidazole gel versus 1% clindamycin gel in adults with moderate acne vulgaris at Jinnah Postgraduate Medical Centre (JPMC), Karachi. Sixty eligible participants (18-35 years) will be enrolled using consecutive sampling and randomized in a 1:1 ratio using blocked randomization. Participants will apply the assigned gel as a thin layer twice daily for 12 weeks. Acne severity will be assessed using the Modified Global Acne Grading System (mGAGS) at baseline and at weeks 4, 8, and 12. The primary outcome is the proportion of participants achieving at least a 50% reduction from baseline in total mGAGS score at week 12. Local adverse effects (e.g., erythema, itching, irritation) will be recorded at each follow-up visit.
Detailed description
This is an investigator-initiated, parallel-group randomized controlled trial (RCT) conducted in the Department of Dermatology, Jinnah Postgraduate Medical Centre (JPMC), Karachi. After approval from the Institutional Review Board (IRB) and the College of Physicians and Surgeons Pakistan (CPSP), adults aged 18-35 years with moderate acne vulgaris, defined by a Modified Global Acne Grading System (mGAGS) score of 45-80, and not using other anti-acne therapies will be enrolled using non-probability consecutive sampling. Participants who are pregnant or lactating, have severe acne (mGAGS >80), have a known allergy to metronidazole or clindamycin, or have other dermatologic conditions affecting the face will be excluded.
Participants will be randomized in a 1:1 allocation using blocked randomization to receive either metronidazole 2% gel or clindamycin 1% gel. The assigned treatment will be applied as a thin layer twice daily (morning and night) for 12 weeks after gentle cleansing and drying of the face. Concomitant anti-acne products will be discouraged during the intervention period. Follow-up assessments will occur at weeks 4, 8, and 12. At each visit, acne severity will be assessed using mGAGS, and tolerability will be evaluated by recording local adverse effects, including erythema, itching, dryness, burning, or irritation.
The primary endpoint is treatment response at week 12, defined as a ≥50% reduction in total mGAGS score from baseline. Participants will be classified as responders (≥50% reduction) or non-responders (<50% reduction). Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Categorical outcomes will be compared using the chi-square test or Fisher's exact test, and continuous variables will be compared using the independent-samples t test or Mann-Whitney U test according to data distribution. Stratified analyses will explore effect modification by age and sex. A two-sided p value ≤0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group, two-arm randomized controlled trial. Eligible participants with moderate acne vulgaris will be randomized in a 1:1 ratio using blocked randomization to receive either 2% metronidazole gel or 1% clindamycin gel, applied twice daily for 12 weeks, with follow-up assessments at weeks 4, 8, and 12.
| Arm | Type | Receives |
|---|---|---|
| Metronidazole 2% Gel | Experimental | Drug: Metronidazole Topical Gel 2%Participants will apply 2% metronidazole gel as a thin layer twice daily (morning and night) for 12 weeks after gentle cleansing and drying. |
| Clindamycin 1% Gel | Active comparator | Drug: Clindamycin Topical Gel 1%Participants will apply 1% clindamycin gel as a thin layer twice daily (morning and night) for 12 weeks after gentle cleansing and drying. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18-35 years of either sex.
- Clinical diagnosis of moderate acne vulgaris, defined as a Modified Global Acne Grading System (mGAGS) score of 45-80.
- Not currently using any other anti-acne treatment (topical or systemic).
Key exclusion criteria (4 listed)
- Pregnant or lactating women.
- Severe acne vulgaris, defined as an mGAGS score >80.
- Known hypersensitivity/allergy to metronidazole or clindamycin (or any component of the study gels).
- Any other dermatologic condition affecting the face that may interfere with assessment of acne severity or treatment response.
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 |
|---|---|---|
| Metronidazole Topical Gel 2%Topical metronidazole gel 2% applied as a thin layer to affected areas twice daily (morning and night) for 12 weeks after gentle cleansing and drying. | Drug | Metronidazole 2% Gel |
| Clindamycin Topical Gel 1%Topical clindamycin gel 1% applied as a thin layer to affected areas twice daily (morning and night) for 12 weeks after gentle cleansing and drying. | Drug | Clindamycin 1% Gel |
Primary outcome
Treatment response by mGAGS at Week 12
Time frame: 12 weeks
Proportion of participants achieving ≥50% reduction in total Modified Global Acne Grading System (mGAGS) score from baseline (Responder = Yes; Non-responder = No).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication20. Verma R, Yadav P, Chudhari M, Patel J, Umrigar D. Comparison of efficacy of two topical drug therapy of acne vulgaris-1% clindamycin versus 5% dapsone: a split-face comparative study. Natl J Physiol Pharm Pharmacol. 2022;12(6):817-822.
- Results publication: PubMed 37190684Irshad M, Syed AW, Shahid MW, Naeem U, Mirza M, Naeem S. Comparative Effects of Azithromycin and Probiotics for Treatment of Acne Vulgaris. J Coll Physicians Surg Pak. 2023 May;33(5):516-520. doi: 10.29271/jcpsp.2023.05.516.
- Results publication: PubMed 34104156Naveed S, Masood S, Rahman A, Awan S, Tabassum S. Impact of acne on quality of life in young Pakistani adults and its relationship with severity: A multicenter study. Pak J Med Sci. 2021 May-Jun;37(3):727-732. doi: 10.12669/pjms.37.3.2819.
- Results publication: PubMed 36568833Dessinioti C, Katsambas A. Antibiotics and Antimicrobial Resistance in Acne: Epidemiological Trends and Clinical Practice Considerations. Yale J Biol Med. 2022 Dec 22;95(4):429-443. eCollection 2022 Dec.
- Results publication: PubMed 37777343Dreno B, Dekio I, Baldwin H, Demessant AL, Dagnelie MA, Khammari A, Corvec S. Acne microbiome: From phyla to phylotypes. J Eur Acad Dermatol Venereol. 2024 Apr;38(4):657-664. doi: 10.1111/jdv.19540. Epub 2023 Oct 11.
- Results publication15. Chen X, et al. Metronidazole: the clinical efficacy and pharmacological effects. Biomedicines. 2023;11(8):2153. doi:10.3390/biomedicines11082153
- Results publication: PubMed 22837561Khodaeiani E, Fouladi RF, Yousefi N, Amirnia M, Babaeinejad S, Shokri J. Efficacy of 2% metronidazole gel in moderate acne vulgaris. Indian J Dermatol. 2012 Jul;57(4):279-81. doi: 10.4103/0019-5154.97666.
- Results publication: PubMed 32424832Nakase K, Aoki S, Sei S, Fukumoto S, Horiuchi Y, Yasuda T, Tanioka M, Sugai J, Huh WW, Kakuta M, Nomoto M, Shimada T, Watanabe M, Kobayashi M, Murakami S, Takeo C, Tsubouchi R, Hayashi N, Noguchi N. Characterization of acne patients carrying clindamycin-resistant Cutibacterium acnes: A Japanese multicenter study. J Dermatol. 2020 Aug;47(8):863-869. doi: 10.1111/1346-8138.15397. Epub 2020 May 18.
- Results publication: PubMed 31844016Aoki S, Nakase K, Nakaminami H, Wajima T, Hayashi N, Noguchi N. Transferable Multidrug-Resistance Plasmid Carrying a Novel Macrolide-Clindamycin Resistance Gene, erm(50), in Cutibacterium acnes. Antimicrob Agents Chemother. 2020 Feb 21;64(3):e01810-19. doi: 10.1128/AAC.01810-19. Print 2020 Feb 21.
- Results publication: PubMed 36880295Koyanagi S, Koizumi J, Nakase K, Hayashi N, Horiuchi Y, Watanabe K, Asai T, Yamazaki A, Nakazaki E, Nakaminami H. Increased frequency of clindamycin-resistant Cutibacterium acnes strains isolated from Japanese patients with acne vulgaris caused by the prevalence of exogenous resistance genes. J Dermatol. 2023 Jun;50(6):793-799. doi: 10.1111/1346-8138.16757. Epub 2023 Mar 7.
- Results publication10. Beig M, et al. Prevalence of antibiotic-resistant Cutibacterium acnes isolated from acne patients: a systematic review and meta-analysis. Lancet Reg Health Southeast Asia. 2024. doi:10.1016/j.lansea.2024.100137
- Results publication: PubMed 38300170Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, Desai SR, Druby KM, Freeman EE, Keri JE, Stein Gold LF, Tan JKL, Tollefson MM, Weiss JS, Wu PA, Zaenglein AL, Han JM, Barbieri JS. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024 May;90(5):1006.e1-1006.e30. doi: 10.1016/j.jaad.2023.12.017. Epub 2024 Jan 30.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared outside the study team. Data will be stored securely at the study site and used only for the purposes described in the protocol. Aggregate, de-identified results will be reported in publications
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole Topical Gel 2% and Clindamycin Topical Gel 1% in people with Acne Vulgaris, run by Jinnah Postgraduate Medical Centre.
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 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rubab Murtaza, FCPS (0334 2341118, rubabumer96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response by mGAGS at Week 12 (time frame: 12 weeks). 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 NCT07392047, which also lists 16 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 6 Feb 2026.