Acne Vulgaris II or III DegreePhase 4NCT07384793
Comparison of Efficacy of Azithromycin Alone vs Combination of Azithromycin and Probiotics in Management of Mild to Moderate Acne Vulgaris
A Phase 4 study testing Azithromycin 250 MG Oral Capsule and Azithromycin 250 MG Oral Capsule Along with Oral Probiotics in people with Acne Vulgaris II or III Degree, run by Hayatabad Medical Complex at 1 site in Pakistan.
Trial summary
The Goal of this Clinical trial is to compare the efficacy of oral azithromycin alone with combination therapy of oral azithromycin and probiotics to see is there any significant difference in outcome of two treatment modalities in mild to moderate acne vulgaris Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Acne Vulgaris II or III Degree
- What is being tested?
- Azithromycin 250 MG Oral Capsule and Azithromycin 250 MG Oral Capsule Along with Oral Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Oct 2025to Apr 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- History of active localized or generalized infection History of autoimmune disease History of other facial skin diseases/ excessive facial hair or scars History of using isotretinoin or oral contraceptive pills in past 6 months History of already using antibiotics for acne treatment History of facial cosmetic procedures within last 3 months History of allergy to drugs used in study History of using drugs that may interact with azithromycin Currently pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
The Goal of this Clinical trial is to compare the efficacy of oral azithromycin alone with combination therapy of oral azithromycin and probiotics to see is there any significant difference in outcome of two treatment modalities in mild to moderate acne vulgaris
- Conditions
- Acne Vulgaris II or III Degree
- Being tested
- Azithromycin 250 MG Oral Capsule, Azithromycin 250 MG Oral Capsule Along with Oral Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin 250 MG Oral CapsuleDrug
The participants in this arm of study will receive only Oral Azithromycin 250mg on alternate day for 12 weeks to treat their Acne
Azithromycin 250 MG Oral Capsule Along with Oral ProbioticsDrug
The participants in this arm of study will receive only Oral Azithromycin 250mg on alternate day along with oral probiotics daily for 12 weeks to treat their Acne
| Study group | Role | What they receive |
|---|---|---|
| Oral Azithromycin group | Active comparator | The participants in this arm of study will receive only Oral Azithromycin to treat their Acne Receives: Drug: Azithromycin 250 MG Oral Capsule |
| Oral Azithromycin and Oral probiotic combination | Active comparator | The participants in this arm of study will receive both Oral Azithromycin and Oral Probiotics to treat their Acne Receives: Drug: Azithromycin 250 MG Oral Capsule Along with Oral Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Acne Lesion Count as per Acne Global assessment scale
The patients will be assessed before and after the treatment and their lesions will be counted .The Primary outcome that will be measured is the reduction of the lesion counts according to the Acne global Assessment scale
The participants included will be with mild to moderate acne on basis of global acne assessment scale score of 2 or 3.
The minimum Lesion count considered will be 20 and the Maximum will be 50.
Lower is better Higher is worse.
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 posted3 Feb 2026
- Study start12 Oct 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Vulgaris II or III DegreeStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayatabad Medical Complex
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Naheed asghar, Hayatabad Medical Complex
- Investigators
- Ayesha Naeem, Study chair, Hayatabad Medical Complex Peshawar, KPK Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384793
- Sponsor's protocol ID
- HMC Peshawar
- Status last verified
- Oct 2025
- First submitted
- 27 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Azithromycin Alone vs Combination of Azithromycin and Probiotics in Management of Mild to Moderate Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07384793
- Acronym / sponsor ID
- HMC Peshawar
- Conditions
- Acne Vulgaris II or III Degree
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hayatabad Medical ComplexOther government
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 3 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.
The Goal of this Clinical trial is to compare the efficacy of oral azithromycin alone with combination therapy of oral azithromycin and probiotics to see is there any significant difference in outcome of two treatment modalities in mild to moderate acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Azithromycin group | Active comparator | Drug: Azithromycin 250 MG Oral CapsuleThe participants in this arm of study will receive only Oral Azithromycin to treat their Acne |
| Oral Azithromycin and Oral probiotic combination | Active comparator | Drug: Azithromycin 250 MG Oral Capsule Along with Oral ProbioticsThe participants in this arm of study will receive both Oral Azithromycin and Oral Probiotics to treat their Acne |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- History of active localized or generalized infection History of autoimmune disease History of other facial skin diseases/ excessive facial hair or scars History of using isotretinoin or oral contraceptive pills in past 6 months History of already using antibiotics for acne treatment History of facial cosmetic procedures within last 3 months History of allergy to drugs used in study History of using drugs that may interact with azithromycin Currently pregnant or lactating women
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 |
|---|---|---|
| Azithromycin 250 MG Oral CapsuleThe participants in this arm of study will receive only Oral Azithromycin 250mg on alternate day for 12 weeks to treat their Acne | Drug | Oral Azithromycin group |
| Azithromycin 250 MG Oral Capsule Along with Oral ProbioticsThe participants in this arm of study will receive only Oral Azithromycin 250mg on alternate day along with oral probiotics daily for 12 weeks to treat their Acne | Drug | Oral Azithromycin and Oral probiotic combination |
Primary outcome
Reduction of Acne Lesion Count as per Acne Global assessment scale
Time frame: 12 Weeks
The patients will be assessed before and after the treatment and their lesions will be counted .The Primary outcome that will be measured is the reduction of the lesion counts according to the Acne global Assessment scale The participants included will be with mild to moderate acne on basis of global acne assessment scale score of 2 or 3. The minimum Lesion count considered will be 20 and the Maximum will be 50. Lower is better Higher is worse.
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 3 Feb 2026.
- Individual participant dataSharing planned: No
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.
Ayesha Naeem study chair
Hayatabad Medical Complex Peshawar, KPK Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin 250 MG Oral Capsule and Azithromycin 250 MG Oral Capsule Along with Oral Probiotics in people with Acne Vulgaris II or III Degree, run by Hayatabad Medical Complex 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 0 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 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. 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?
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?
Reduction of Acne Lesion Count as per Acne Global assessment scale (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 3 Feb 2026.