CorneaNCT06483971
Comparison of Oral Isotretinoin vs Ancomparison of Oral Isotretinoin vs Antibiotics on Corneal Thickness With AV
A study testing Oral Isotretinoin and Antibiotics in people with Cornea, run by Superior University at 1 site in Pakistan.
Trial summary
Comparison of Oral Isotretinoin versus comparison of Oral Isotretinoin versus Antibiotics on Corneal Thickness in Patients with Acne Vulgaris Read more about this study
- Who is it for?
- Ages 20 to 43 years
- Conditions the study is for
- Cornea
- What is being tested?
- Oral Isotretinoin and Antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Oct 2024
- Phase
- Interventional
- 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 20 to 43 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of either gender shall be enrolled for this study.
- Acne vulgaris patients taking oral isotretinoin and oral antibiotics shall be included.
Who cannot join
- Patients with any ocular pathology shall be excluded.
- Patients with any systemic pathology other than acne vulgaris shall be excluded.
- Patients with history of contact lens wear, previous refractive surgery or injury shall be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Oral Isotretinoin Versus Ancomparison of Oral Isotretinoin Versus Antibiotics on Corneal Thickness in Patients With Acne Vulgaris
Comparison of Oral Isotretinoin versus comparison of Oral Isotretinoin versus Antibiotics on Corneal Thickness in Patients with Acne Vulgaris
Read the detailed description
Acne is the most common skin disease requiring attention of health practitioners. It is a self-limiting disease of the pilosebaceous unit, which can lead to devastating and frustrating scars and pigmentary alterations.
- Conditions
- Cornea
- Being tested
- Oral Isotretinoin, Antibiotics
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral IsotretinoinDiagnostic test
20 mg/kg/day that affects sebaceous glands and is used to treat severe acne Frequency: Once daily
AntibioticsCombination product
250 mg on laternate day/3 months Frequency: Once or twice daily
| Study group | Role | What they receive |
|---|---|---|
| Oral Isotretinoin | Other | Not described Receives: Diagnostic Test: Oral Isotretinoin |
| Antibiotics | Experimental | Not described Receives: Combination Product: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical Coherence Tomography (OCT)
Standardized OCT imaging protocols to ensure consistency and accuracy across all measurements.
Measured: 12 Months
Snellen Chart
Visual acuity measured at 3-month and 6-month intervals. Units: Snellen fraction (e.g., 20/20, 20/40)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Nov 2023
- Primary completion1 Jun 2024
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483971
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/731
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Isotretinoin Versus Ancomparison of Oral Isotretinoin Versus Antibiotics on Corneal Thickness in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06483971
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/731
- Conditions
- Cornea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
Comparison of Oral Isotretinoin versus comparison of Oral Isotretinoin versus Antibiotics on Corneal Thickness in Patients with Acne Vulgaris
Detailed description
Acne is the most common skin disease requiring attention of health practitioners. It is a self-limiting disease of the pilosebaceous unit, which can lead to devastating and frustrating scars and pigmentary alterations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Isotretinoin | Other | Diagnostic Test: Oral Isotretinoin |
| Antibiotics | Experimental | Combination Product: Antibiotics |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients of either gender shall be enrolled for this study.
- Acne vulgaris patients taking oral isotretinoin and oral antibiotics shall be included.
Key exclusion criteria (3 listed)
- Patients with any ocular pathology shall be excluded.
- Patients with any systemic pathology other than acne vulgaris shall be excluded.
- Patients with history of contact lens wear, previous refractive surgery or injury shall be excluded.
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 |
|---|---|---|
| Oral Isotretinoin20 mg/kg/day that affects sebaceous glands and is used to treat severe acne Frequency: Once daily | Diagnostic test | Oral Isotretinoin |
| Antibiotics250 mg on laternate day/3 months Frequency: Once or twice daily | Combination product | Antibiotics |
Primary outcome
Optical Coherence Tomography (OCT)
Time frame: 12 Months
Standardized OCT imaging protocols to ensure consistency and accuracy across all measurements.
Snellen Chart
Time frame: 12 months
Visual acuity measured at 3-month and 6-month intervals. Units: Snellen fraction (e.g., 20/20, 20/40)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Cornea
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Not yet recruiting
A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
Cornea Disease
Recruiting
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Corneal Diseases, Retinal Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Isotretinoin and Antibiotics in people with Cornea, run by Superior University 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 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
Optical Coherence Tomography (OCT) (time frame: 12 Months). 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?
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 Jul 2024.