Comparing the Efficacy and Safety of Low-Dose Oral Isotretinoin Versus Conventional-Dose in the Treatment of Acne Vulgaris
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 164
- Locations
- 1
Study Overview
Brief 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.
Detailed Description
This is a randomized, comparative clinical study designed to evaluate and compare the therapeutic efficacy and safety profile of two different dosing regimens of oral isotretinoin in patients diagnosed with acne vulgaris.
Eligible participants will be allocated into one of two treatment arms:
- Experimental Arm (Low Dose): Participants will receive a low daily dose of oral isotretinoin.
- Active Comparator Arm (Conventional Dose): Participants will receive the standard conventional daily dose of oral isotretinoin based on standard weight-based guidelines.
Primary Outcome:
Efficacy: Assessed by the percentage reduction in inflammatory and non-inflammatory acne lesions from baseline, as well as The Global Acne grading System(GAGS) Safety and Tolerability: Evaluated through the frequency, type, and severity of clinical adverse effects (e.g., cheilitis, xerosis) and periodic laboratory monitoring (including lipid profiles and liver function tests).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Both genders
- •Age 18-45 years
- •Patients who are clinically diagnosed with moderate to severe acne vulgaris as per criteria defined in operational definition.
Exclusion Criteria
- •Patients who are pregnant or lactating
- •Patients with history of endocrine disorders such as PCOS etc. or having drug induced acne
- •Patients on corticosteroid treatment
- •Patients who have hypersensitivity to the isotretinoin
- •Patients who are taking any acne treatment
- •Patients with hyperlipidemia, chronic renal failure or liver failure
Investigators
Nareeman Ur Rehman
FCPS Resident, Department of Dermatology
Pakistan Institute of Medical Sciences