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NCT Number: NCT07639073

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pakistan Institute of Medical Sciences(PIMS)

Islamabad, Pakistan

Location contact

Dr Nareeman Ur Rehman, MBBS,FCPS

CONTACT

[email protected]

+923169560013

About this study

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).

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isotretinoin

Drug

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.

Other names: Accutane, Roaccutane

Primary outcomes

  1. Change from baseline in Global Acne Grading System(GAGS)Scoring

    Time frame: 12 weeks

    The GAGS is a validated scoring system that calculates acne severity across six specific facial and torso areas (forehead, right cheek, left cheek, nose, chin, and chest/upper back). Each area is assigned a factor based on size, and lesions are graded from 0 (no lesions) to 4 (cystic lesions). The total score ranges from 0 to 44, where 0 is clear and higher scores indicate greater severity. Efficacy will be compared between the low-dose and conventional-dose arms based on the mean reduction in total GAGS score from baseline.

  2. Percentage change in total acne lesion count from baseline

    Time frame: 12 weeks

    The total lesion count is calculated by adding the number of inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones) on the face according to GAGS. Efficacy will be compared between the low-dose and conventional-dose arms based on the percentage reduction from day 0.

Secondary outcomes

  1. Incidence and severity of treatment-emergent adverse events (TEAEs)

    Time frame: 12 weeks

    Frequency and severity of clinical side effects (such as cheilitis, xerosis/dry skin, conjunctivitis) and laboratory abnormalities (such as elevated liver enzymes or lipid profiles) will be evaluated and compared between the two dosing groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Nareeman Ur Rehman, MBBS, FCPS

CONTACT

[email protected]

+923169560013

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Official study title

Comparing the Efficacy and Safety of Low-Dose Oral Isotretinoin Versus Conventional-Dose in the Treatment of Acne Vulgaris

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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