Acne VulgarisAcne vulgarisNCT07539129
Investigating the Efficacy of Oral Probiotics Versus Placebo in Pakistani Patients With Moderate Acne on Acne Lesion Count and Systemic Inflammation
A study testing Probiotics in people with Acne Vulgaris, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This randomized controlled trial evaluates the efficacy of oral probiotics compared to placebo in Pakistani patients with moderate Acne Vulgaris. Acne is a multifactorial inflammatory disorder influenced by microbial colonization, seborrhea, and immune dysregulation. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2026to 1 Aug 2027
- Phase
- Interventional
- 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female patients aged 15-35 years
- Clinical diagnosis of moderate acne vulgaris
- Fitzpatrick skin types III-V
- Willing to provide informed consent and comply with study protocol
Who cannot join
- Severe nodulocystic acne, acne conglobata, or acne fulminans
- Oral antibiotics, isotretinoin, or hormonal therapy within past 4 weeks
- Topical anti-acne therapy within past 2 weeks
- Current probiotic supplementation
- Chronic inflammatory or autoimmune disease
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Fauji Foundation Hospital, Rawalpindi
Rawalpindi, Punjab Province, 46000
Dr. Aima Tariq, FCPS, +923359844189, aimatariq1@gmail.com
Dr. Ayesha Saeed, Ph.D. Biotechnology, +923325756579, ayeshasaeed@fui.edu.pk
About this study
Official title: A Randomized Controlled Trial Investigating the Efficacy of Oral Probiotics Versus Placebo in Pakistani Patients With Moderate Acne on Acne Lesion Count and Systemic Inflammation (Interleukin-6) Levels
This randomized controlled trial evaluates the efficacy of oral probiotics compared to placebo in Pakistani patients with moderate Acne Vulgaris. Acne is a multifactorial inflammatory disorder influenced by microbial colonization, seborrhea, and immune dysregulation. Rising antibiotic resistance necessitates alternative therapeutic approaches. Emerging evidence highlights the gut-skin axis, suggesting probiotics may reduce systemic inflammation and acne severity. A total of 64 patients will be randomized into probiotic and placebo groups and treated for 12 weeks. The primary outcome is reduction in total acne lesion count, while the secondary outcome is change in serum Interleukin-6 levels. Clinical assessment includes lesion counts, GAGS scoring, and standardized photography. IL-6 levels will be measured using ELISA at baseline and study completion. Data will be analyzed using SPSS with appropriate statistical tests, considering p ≤ 0.05 as significant. This study aims to provide evidence for probiotics as a safe, effective, and antibiotic-sparing option in acne management, particularly in South Asian populations.
Read the detailed description
This randomized placebo-controlled trial evaluated the effectiveness of oral probiotics in patients with moderate acne vulgaris in Pakistan. Acne is a chronic inflammatory condition of the pilosebaceous unit with multifactorial pathogenesis involving sebum overproduction, follicular hyperkeratinization, microbial colonization, and inflammation. Conventional therapies, particularly antibiotics, are increasingly limited by resistance, prompting exploration of alternative treatments. Emerging evidence suggests a link between gut microbiota and skin inflammation, supporting the potential role of probiotics in acne management.
A total of 64 patients aged 18-35 years with moderate acne were enrolled and randomly assigned to receive either oral probiotic sachets or placebo once daily for 12 weeks. The probiotic preparation contained multiple strains including Lactobacillus and Bifidobacterium species. Baseline assessment included lesion counts, Global Acne Grading System scoring, and serum interleukin-6 levels. Follow-up evaluations were conducted at regular intervals to monitor clinical response, compliance, and adverse effects.
The primary outcome was reduction in total acne lesion count, while the secondary outcome was change in systemic inflammation measured by IL-6 levels. Blood samples were collected at baseline and at the end of treatment for cytokine analysis using ELISA. Standardized skincare was maintained for all participants to minimize confounding factors.
Data were analyzed using appropriate statistical tests, with significance set at p ≤ 0.05. Ethical approval was obtained, and informed consent was secured from all participants. The study aimed to determine whether probiotics could provide a safe and effective adjunct or alternative to conventional acne therapies by reducing both clinical severity and systemic inflammation.
- Conditions
- Acne Vulgaris
- Being tested
- Probiotics, Placebo
- Keywords
- Acne Vulgaris, Modrate Acne, Probiotics, Inflammatory markers, Interleukin 6, Ecotec TM
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Participants will receive a standardized multi-strain oral probiotic (Ecotec sachet) once daily for 12 weeks alongside standard acne care. The formulation contains Lactobacillus and Bifidobacterium species aimed at modulating the gut-skin axis and reducing systemic inflammation.
PlaceboOther
Participants will receive a placebo sachet identical in appearance, taste, and packaging to the probiotic, administered once daily for 12 weeks alongside standard acne care. The placebo contains inert ingredients with no active probiotic strains, ensuring blinding and allowing accurate comparison of treatment outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Oral Probiotics | Experimental | Participants receive oral probiotic sachets (Ecotec®) once daily for 12 weeks. Each sachet contains a combination of Lactobacillus acidophilus, Bifidobacterium species, Streptococcus thermophilus, and Lactobacillus delbrueckii. The sachet is dissolved in water and taken after meals.Describe the intervention(s) to be administered.
For drugs use generic name and include dosage form, dosage, frequency and duration. Receives: Dietary Supplement: Probiotics |
| Oral Plecebo | Placebo comparator | Participants receive a placebo sachet identical in appearance, taste, and packaging to the probiotic, administered once daily for 12 weeks. The placebo contains inactive ingredients with no therapeutic effect. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction in total acne lesion count
Reduction in total acne lesion count from baseline to 12 weeks, assessed using standardized lesion counting and Global Acne Grading System (GAGS).
Measured: 12 weeks
Secondary outcomes (1)
Mean reduction in serum Interleukin-6 (IL-6) levels
Change in serum IL-6 levels from baseline to Week 12, measured using ELISA. Greater reduction indicates decreased systemic inflammation.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- Model description
- This is a parallel-group randomized controlled trial. Participants with moderate acne vulgaris will be randomly assigned to either oral probiotics vs oral placebo
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Collaborators
- Fauji Foundation Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539129
- Sponsor's protocol ID
- FUMCRCT7
- Acronym
- Acne vulgaris
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee YB, Byun EJ, Kim HS. Potential Role of the Microbiome in Acne: A Comprehensive Review. J Clin Med. 2019 Jul 7;8(7):987. doi: 10.3390/jcm8070987.
PubMed 31284694Reynolds 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 38300170Zhao Y, Yu C, Zhang J, Yao Q, Zhu X, Zhou X. The gut-skin axis: Emerging insights in understanding and treating skin diseases through gut microbiome modulation (Review). Int J Mol Med. 2025 Dec;56(6):210. doi: 10.3892/ijmm.2025.5651. Epub 2025 Oct 3.
PubMed 41041846Mohamed M, Ullah A, Hassan R, Hamza M, Mohamed I, Salam M. The Impact of Probiotics on Acne Vulgaris: A Meta-Analysis of Randomized Controlled Trials. Cureus. 2025 Nov 16;17(11):e97010. doi: 10.7759/cureus.97010. eCollection 2025 Nov.
PubMed 41416302Burckhardt-Bravo V, Funes-Ferrada R, Valenzuela F. Update on novel acne treatments: a narrative review focused on microbiome modulation and non-pharmacological approaches. An Bras Dermatol. 2026 Jan-Feb;101(1):501249. doi: 10.1016/j.abd.2025.501249. Epub 2026 Jan 15.
PubMed 41544313Ashkanani A, Ashkanani G, Yousef M, Rob M, Al-Marri M, Naseem N, Laws S, Chaari A. Microbiome and Skin Health: A Systematic Review of Nutraceutical Interventions, Disease Severity, Inflammation, and Gut Microbiota. Microorganisms. 2025 Dec 26;14(1):63. doi: 10.3390/microorganisms14010063.
PubMed 41597583Warp PV, Bilik SM, Ferrari LM, Keri JE. Prebiotics, Probiotics, and Postbiotics for Acne Vulgaris: A Systematic Review. Dermatol Ther (Heidelb). 2026 Mar;16(3):1531-1550. doi: 10.1007/s13555-026-01659-4. Epub 2026 Feb 17.
PubMed 41703218
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Investigating the Efficacy of Oral Probiotics Versus Placebo in Pakistani Patients With Moderate Acne on Acne Lesion Count and Systemic Inflammation (Interleukin-6) Levels
- ClinicalTrials.gov ID
- NCT07539129
- Acronym / sponsor ID
- Acne vulgaris / FUMCRCT7
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Modrate Acne, Probiotics, Inflammatory markers, Interleukin 6, Ecotec TM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Collaborators
- Fauji Foundation Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 20 Apr 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.
This randomized controlled trial evaluates the efficacy of oral probiotics compared to placebo in Pakistani patients with moderate Acne Vulgaris. Acne is a multifactorial inflammatory disorder influenced by microbial colonization, seborrhea, and immune dysregulation. Rising antibiotic resistance necessitates alternative therapeutic approaches. Emerging evidence highlights the gut-skin axis, suggesting probiotics may reduce systemic inflammation and acne severity. A total of 64 patients will be randomized into probiotic and placebo groups and treated for 12 weeks. The primary outcome is reduction in total acne lesion count, while the secondary outcome is change in serum Interleukin-6 levels. Clinical assessment includes lesion counts, GAGS scoring, and standardized photography. IL-6 levels will be measured using ELISA at baseline and study completion. Data will be analyzed using SPSS with appropriate statistical tests, considering p ≤ 0.05 as significant. This study aims to provide evidence for probiotics as a safe, effective, and antibiotic-sparing option in acne management, particularly in South Asian populations.
Detailed description
This randomized placebo-controlled trial evaluated the effectiveness of oral probiotics in patients with moderate acne vulgaris in Pakistan. Acne is a chronic inflammatory condition of the pilosebaceous unit with multifactorial pathogenesis involving sebum overproduction, follicular hyperkeratinization, microbial colonization, and inflammation. Conventional therapies, particularly antibiotics, are increasingly limited by resistance, prompting exploration of alternative treatments. Emerging evidence suggests a link between gut microbiota and skin inflammation, supporting the potential role of probiotics in acne management.
A total of 64 patients aged 18-35 years with moderate acne were enrolled and randomly assigned to receive either oral probiotic sachets or placebo once daily for 12 weeks. The probiotic preparation contained multiple strains including Lactobacillus and Bifidobacterium species. Baseline assessment included lesion counts, Global Acne Grading System scoring, and serum interleukin-6 levels. Follow-up evaluations were conducted at regular intervals to monitor clinical response, compliance, and adverse effects.
The primary outcome was reduction in total acne lesion count, while the secondary outcome was change in systemic inflammation measured by IL-6 levels. Blood samples were collected at baseline and at the end of treatment for cytokine analysis using ELISA. Standardized skincare was maintained for all participants to minimize confounding factors.
Data were analyzed using appropriate statistical tests, with significance set at p ≤ 0.05. Ethical approval was obtained, and informed consent was secured from all participants. The study aimed to determine whether probiotics could provide a safe and effective adjunct or alternative to conventional acne therapies by reducing both clinical severity and systemic inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel-group randomized controlled trial. Participants with moderate acne vulgaris will be randomly assigned to either oral probiotics vs oral placebo
| Arm | Type | Receives |
|---|---|---|
| Oral Probiotics | Experimental | Dietary Supplement: ProbioticsParticipants receive oral probiotic sachets (Ecotec®) once daily for 12 weeks. Each sachet contains a combination of Lactobacillus acidophilus, Bifidobacterium species, Streptococcus thermophilus, and Lactobacillus delbrueckii. The sachet is dissolved in water and taken after meals.Describe the intervention(s) to be administered. For drugs use generic name and include dosage form, dosage, frequency and duration. |
| Oral Plecebo | Placebo comparator | Other: PlaceboParticipants receive a placebo sachet identical in appearance, taste, and packaging to the probiotic, administered once daily for 12 weeks. The placebo contains inactive ingredients with no therapeutic effect. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male and female patients aged 15-35 years
- Clinical diagnosis of moderate acne vulgaris
- Fitzpatrick skin types III-V
- Willing to provide informed consent and comply with study protocol
Key exclusion criteria (6 listed)
- Severe nodulocystic acne, acne conglobata, or acne fulminans
- Oral antibiotics, isotretinoin, or hormonal therapy within past 4 weeks
- Topical anti-acne therapy within past 2 weeks
- Current probiotic supplementation
- Chronic inflammatory or autoimmune disease
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 |
|---|---|---|
| ProbioticsParticipants will receive a standardized multi-strain oral probiotic (Ecotec sachet) once daily for 12 weeks alongside standard acne care. The formulation contains Lactobacillus and Bifidobacterium species aimed at modulating the gut-skin axis and reducing systemic inflammation. | Dietary supplement | Oral Probiotics |
| PlaceboParticipants will receive a placebo sachet identical in appearance, taste, and packaging to the probiotic, administered once daily for 12 weeks alongside standard acne care. The placebo contains inert ingredients with no active probiotic strains, ensuring blinding and allowing accurate comparison of treatment outcomes. | Other | Oral Plecebo |
Primary outcome
Mean reduction in total acne lesion count
Time frame: 12 weeks
Reduction in total acne lesion count from baseline to 12 weeks, assessed using standardized lesion counting and Global Acne Grading System (GAGS).
1 secondary outcome
Mean reduction in serum Interleukin-6 (IL-6) levels
Time frame: Baseline to 12 weeks
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 20 Apr 2026.
- Background: PubMed 31284694Lee YB, Byun EJ, Kim HS. Potential Role of the Microbiome in Acne: A Comprehensive Review. J Clin Med. 2019 Jul 7;8(7):987. doi: 10.3390/jcm8070987.
- Background: 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.
- Background: PubMed 41041846Zhao Y, Yu C, Zhang J, Yao Q, Zhu X, Zhou X. The gut-skin axis: Emerging insights in understanding and treating skin diseases through gut microbiome modulation (Review). Int J Mol Med. 2025 Dec;56(6):210. doi: 10.3892/ijmm.2025.5651. Epub 2025 Oct 3.
- Background: PubMed 41416302Mohamed M, Ullah A, Hassan R, Hamza M, Mohamed I, Salam M. The Impact of Probiotics on Acne Vulgaris: A Meta-Analysis of Randomized Controlled Trials. Cureus. 2025 Nov 16;17(11):e97010. doi: 10.7759/cureus.97010. eCollection 2025 Nov.
- Background: PubMed 41544313Burckhardt-Bravo V, Funes-Ferrada R, Valenzuela F. Update on novel acne treatments: a narrative review focused on microbiome modulation and non-pharmacological approaches. An Bras Dermatol. 2026 Jan-Feb;101(1):501249. doi: 10.1016/j.abd.2025.501249. Epub 2026 Jan 15.
- Background: PubMed 41597583Ashkanani A, Ashkanani G, Yousef M, Rob M, Al-Marri M, Naseem N, Laws S, Chaari A. Microbiome and Skin Health: A Systematic Review of Nutraceutical Interventions, Disease Severity, Inflammation, and Gut Microbiota. Microorganisms. 2025 Dec 26;14(1):63. doi: 10.3390/microorganisms14010063.
- Background: PubMed 41703218Warp PV, Bilik SM, Ferrari LM, Keri JE. Prebiotics, Probiotics, and Postbiotics for Acne Vulgaris: A Systematic Review. Dermatol Ther (Heidelb). 2026 Mar;16(3):1531-1550. doi: 10.1007/s13555-026-01659-4. Epub 2026 Feb 17.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Acne Vulgaris, run by Foundation University Islamabad 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 4 inclusion and 6 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 20 Apr 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. 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.
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 Dr. Aima Tariq, FCPS, Fellowship in Derma (+923359844189, aimatariq1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean reduction in total acne lesion count (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 NCT07539129, which also lists 7 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 20 Apr 2026.