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.

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:

1. Experimental Arm (Low Dose): Participants will receive a low daily dose of oral isotretinoin.
2. 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).

Follow-up visits will be conducted at regular intervals to monitor clinical response, manage side effects, and ensure patient compliance.

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

De-identified individual participant data underlying the principal results of this study (including demographic data, baseline characteristics, efficacy outcomes, and safety parameters) will be made available to ensure transparency and validate study findings.

Data will become available starting 6 months after the primary publication of the study results and will remain accessible for up to 3 years

Anonymized individual participant data will be shared with qualified academic researchers upon reasonable request directed to the corresponding author. Requests must be accompanied by a sound, formal research proposal and require a signed data-use agreement.