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Low-Dose Versus Conventional-Dose Oral Isotretinoin for Acne Vulgaris
Sponsor: Pakistan Institute of Medical Sciences
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.
Official title: Comparing the Efficacy and Safety of Low-Dose Oral Isotretinoin Versus Conventional-Dose in the Treatment of Acne Vulgaris
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2026-07
Completion Date
2026-10
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
Isotretinoin
Oral isotretinoin capsules administered daily to participants for the treatment of acne vulgaris. This study evaluates two distinct dosing regimens to compare their relative efficacy and safety: 1) Low-Dose Regimen: Participants receive a reduced daily dose (e.g. 0.25 mg/kg/day). 2) Conventional-Dose Regimen: Participants receive the standard weight-based dose (e.g., 0.5 mg/kg/day). Treatment duration, monitoring schedules, and dose adjustments follow protocol specifications.
Locations (1)
Pakistan Institute of Medical Sciences(PIMS)
Islamabad, Pakistan