Acne VulgarisPhase 3NCT05629468
Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris
A Phase 3 study testing Azithromycin, Probiotic Formula and Benzoyl Peroxide 4 % Topical Cream in people with Acne Vulgaris, run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial summary
the goal of this clinical trial is to measure the efficacy of probiotics for treatment of acne vulgaris, to compare it with azithromycin and to measure the synergistic effect of azithromycin and probiotics for treatment of acne vulgaris 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?
- Azithromycin, Probiotic Formula and Benzoyl Peroxide 4 % Topical Cream
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2021to 31 Aug 2022
- Phase
- Phase 3
- 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed Patients of Mild and Moderate acne
- Aged between 15 and 35 years
Who cannot join
- Severe acne or any systemic inflammatory disease
- Other oral treatment for acne
- Allergic to any drug being used in the study
- Pregnancy
- PCOs
- Any drug which can interact with azithromycin
Trial locations and contacts
1 site in 1 country.
About this study
the goal of this clinical trial is to measure the efficacy of probiotics for treatment of acne vulgaris, to compare it with azithromycin and to measure the synergistic effect of azithromycin and probiotics for treatment of acne vulgaris
Read the detailed description
this study aims to answer this research question: in patients of acne vulgaris, is use of probiotics as efficacious as azithromycin in treating acne lesions \& improving quality of life? total 75 patients were divided into 3 groups. group A received azithromycin, group B received probiotics and group C received both drugs. a topical cream was also advised to all groups. outcome was measured as reduction in total lesion count and improvement in patients' quality of life via reduction in Dermatology Life Quality Index score.
- Conditions
- Acne Vulgaris
- Being tested
- Azithromycin, Probiotic Formula, Benzoyl Peroxide 4 % Topical Cream
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called "Zetro" by "Getz Pharma"
antibiotic
Probiotic FormulaDrug
Also called "Hi-Flora" by "Unicare Bioceuticals"
probiotics
Benzoyl Peroxide 4 % Topical CreamDrug
Also called "Benoxyl" by "Glitz pharma"
topical cream
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin and Topical | Active comparator | group A (n=25) received tab. azithromycin 250mg oral on alternate days and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months Receives: Drug: Azithromycin; Drug: Benzoyl Peroxide 4 % Topical Cream |
| Probiotics and Topical | Experimental | group B (n=25) received Probiotic sachet oral once a day everyday and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months Receives: Drug: Probiotic Formula; Drug: Benzoyl Peroxide 4 % Topical Cream |
| Azithromycin and Probiotics and Topical | Other | combination group C (n=25) received tab. azithromycin 250mg oral on alternate days, Probiotic sachet oral once a day everyday and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months Receives: Drug: Azithromycin; Drug: Probiotic Formula; Drug: Benzoyl Peroxide 4 % Topical Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
change or reduction in the Total Lesion Count
number of acne lesions are counted at every follow up to see whether lesions are reduced than the baseline or not
Measured: at start of the study (baseline), 2 weeks (1st follow up visit), 4 weeks (2nd follow up visit), 8 weeks (3rd follow up visit) and 12 weeks (4th follow up visit).
Secondary outcomes (1)
change or reduction in the Dermatology Life Quality Index score
improvement in patients' quality of life was assessed to see whether the score has been reduced than the baseline score or not. it was assessed by a 10-item self assessment questionnaire i.e Dermatology Life Quality Index. the score ranges between 0 to 30. higher score means worst outcome and the lower score means better outcome.
Measured: at start of the study (baseline) and 12 weeks (last follow up visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start15 Oct 2021
- Primary completion30 Jun 2022
- Study completion31 Aug 2022
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mushayada Irshad, Pak Emirates Military Hospital
- Investigators
- Akbar W Syed, PhD, Study director, Riphah International University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629468
- Sponsor's protocol ID
- A/28/EC/337/2021
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 5 Dec 2022
- 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 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT05629468
- Acronym / sponsor ID
- A/28/EC/337/2021
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 29 Nov 2022 (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 measure the efficacy of probiotics for treatment of acne vulgaris, to compare it with azithromycin and to measure the synergistic effect of azithromycin and probiotics for treatment of acne vulgaris
Detailed description
this study aims to answer this research question: in patients of acne vulgaris, is use of probiotics as efficacious as azithromycin in treating acne lesions \& improving quality of life? total 75 patients were divided into 3 groups. group A received azithromycin, group B received probiotics and group C received both drugs. a topical cream was also advised to all groups. outcome was measured as reduction in total lesion count and improvement in patients' quality of life via reduction in Dermatology Life Quality Index score.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Azithromycin and Topical | Active comparator | Drug: Azithromycin, Drug: Benzoyl Peroxide 4 % Topical Creamgroup A (n=25) received tab. azithromycin 250mg oral on alternate days and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months |
| Probiotics and Topical | Experimental | Drug: Probiotic Formula, Drug: Benzoyl Peroxide 4 % Topical Creamgroup B (n=25) received Probiotic sachet oral once a day everyday and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months |
| Azithromycin and Probiotics and Topical | Other | Drug: Azithromycin, Drug: Probiotic Formula, Drug: Benzoyl Peroxide 4 % Topical Creamcombination group C (n=25) received tab. azithromycin 250mg oral on alternate days, Probiotic sachet oral once a day everyday and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosed Patients of Mild and Moderate acne
- Aged between 15 and 35 years
Key exclusion criteria (6 listed)
- Severe acne or any systemic inflammatory disease
- Other oral treatment for acne
- Allergic to any drug being used in the study
- Pregnancy
- PCOs
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 |
|---|---|---|
| AzithromycinAlso: "Zetro" by "Getz Pharma"antibiotic | Drug | Azithromycin and Probiotics and Topical, Azithromycin and Topical |
| Probiotic FormulaAlso: "Hi-Flora" by "Unicare Bioceuticals"probiotics | Drug | Azithromycin and Probiotics and Topical, Probiotics and Topical |
| Benzoyl Peroxide 4 % Topical CreamAlso: "Benoxyl" by "Glitz pharma"topical cream | Drug | Azithromycin and Probiotics and Topical, Azithromycin and Topical, Probiotics and Topical |
Primary outcome
change or reduction in the Total Lesion Count
Time frame: at start of the study (baseline), 2 weeks (1st follow up visit), 4 weeks (2nd follow up visit), 8 weeks (3rd follow up visit) and 12 weeks (4th follow up visit).
number of acne lesions are counted at every follow up to see whether lesions are reduced than the baseline or not
1 secondary outcome
change or reduction in the Dermatology Life Quality Index score
Time frame: at start of the study (baseline) and 12 weeks (last follow up visit).
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 5 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Akbar W Syed, PhD study director
Riphah International University, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin, Probiotic Formula and Benzoyl Peroxide 4 % Topical Cream in people with Acne Vulgaris, run by Pak Emirates Military Hospital 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 2 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: finished, as of the sponsor's last update on 5 Dec 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
change or reduction in the Total Lesion Count (time frame: at start of the study (baseline), 2 weeks (1st follow up visit), 4 weeks (2nd follow up visit), 8 weeks (3rd follow up visit) and 12 weeks (4th follow up visit).). 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 5 Dec 2022.