Comparison of Oral Isotretinoin vs Ancomparison of Oral Isotretinoin vs Antibiotics on Corneal Thickness With AV

June 26, 2024 updated by: Muhammad Naveed Babur, Superior University

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Shalamar Hospital Mughalpura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of either gender shall be enrolled for this study.
  • Acne vulgaris patients taking oral isotretinoin and oral antibiotics shall be included.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Oral Isotretinoin
Diagnostic test: Oral Isotretinoin
20 mg/kg/day that affects sebaceous glands and is used to treat severe acne Frequency: Once daily
Experimental: Antibiotics
Combination product: Antibiotics
250 mg on laternate day/3 months Frequency: Once or twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optical Coherence Tomography (OCT)
Time Frame: 12 Months
Standardized OCT imaging protocols to ensure consistency and accuracy across all measurements.
12 Months
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)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSRSW/Batch-Fall22/731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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