drugset / Trial / NCT07639073

Low-Dose Versus Conventional-Dose Oral Isotretinoin for Acne Vulgaris

NCT07639073

Phase 4 Not yet recruiting 164 enrolled Pakistan Institute of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

Background and Purpose: Acne vulgaris is a common skin condition that can cause significant physical and emotional distress. Oral isotretinoin is a highly effective treatment for severe or persistent acne. While the standard (conventional) dose is effective, it is often associated with side effects like dry skin, chapped lips, and altered labs. The purpose of this study is to compare a lower daily dose of oral isotretinoin against the conventional daily dose in individuals with acne vulgaris. What the Study Aims to Find Out: Researchers want to determine if a low-dose regimen can match the effectiveness (efficacy) of the conventional dose while reducing the frequency and severity of side effects (safety). Study Design: Participants will be randomly assigned to receive either the low-dose oral isotretinoin or the conventional-dose oral isotretinoin. Researchers will monitor and compare acne clearance rates, patient satisfaction, and any side effects experienced by the participants throughout the treatment period.

Timeline

Start
2026-07
Primary completion
2026-10
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Isotretinoin Other / unclassified 0.25 mg/kg Oral
Subject Isotretinoin Other / unclassified 0.5 mg/kg Oral

Indications