NCT06483971

Brief Summary

Comparison of Oral Isotretinoin versus comparison of Oral Isotretinoin versus Antibiotics on Corneal Thickness in Patients with Acne Vulgaris

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 26, 2024

Last Update Submit

June 26, 2024

Conditions

Cornea

Outcome Measures

Primary Outcomes (2)

  • Optical Coherence Tomography (OCT)

    Standardized OCT imaging protocols to ensure consistency and accuracy across all measurements.

    12 Months

  • Snellen Chart

    Visual acuity measured at 3-month and 6-month intervals. Units: Snellen fraction (e.g., 20/20, 20/40)

    12 months

Study Arms (2)

Oral Isotretinoin

OTHER
Diagnostic Test: Oral Isotretinoin

Antibiotics

EXPERIMENTAL
Combination Product: Antibiotics

Interventions

Oral IsotretinoinDIAGNOSTIC_TEST

20 mg/kg/day that affects sebaceous glands and is used to treat severe acne Frequency: Once daily

Oral Isotretinoin
AntibioticsCOMBINATION_PRODUCT

250 mg on laternate day/3 months Frequency: Once or twice daily

Antibiotics

Eligibility Criteria

Age20 Years - 43 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalamar Hospital Mughalpura

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Corneal Diseases

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

November 1, 2023

Primary Completion

June 1, 2024

Study Completion

October 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)