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

NCT07639073 | Not Yet Recruiting Phase 4

• 1 other identifier: PIMS-DERM-ISO-2026-01
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

Isotretinoin; Accutane; Acne Treatment; Dermatology; Low dose Isotretinoin; Conventional Dose Isotretinoin; Retinoids

Outcome Measures

Primary Outcomes (2)

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

  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.

  12 weeks

• Percentage change in total acne lesion count from baseline

  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.

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (2)

Low Dose Oral Isotretinoin

EXPERIMENTAL

Participants in this arm will receive a low-dose regimen of oral isotretinoin (e.g., 0.25mg/kg/day for the duration of the treatment period to evaluate its efficacy and safety in acne vulgaris.

Drug: Isotretinoin

Conventional Dose Oral Isotretinoin

ACTIVE COMPARATOR

participants in this arm will receive conventional dose of oral isotretinoin (e.g. 0.5 mg/kg/day) for the duration of the treatment period to evaluate its efficacy and safety in acne vulgaris.

Drug: Isotretinoin

Interventions

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.

Also known as: Accutane, Roaccutane

Conventional Dose Oral Isotretinoin; Low Dose Oral Isotretinoin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders
• Age 18-45 years
• Patients who are clinically diagnosed with moderate to severe acne vulgaris as per criteria defined in operational definition.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Pakistan Institute of Medical Sciences(PIMS)

Islamabad, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Dr Nareeman Ur Rehman, MBBS, FCPS

  Pakistan Institute of Medical Sciences (PIMS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Nareeman Ur Rehman, MBBS, FCPS

CONTACT

+923169560013; naree.khan1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS Resident, Department of Dermatology

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available starting 6 months after the primary publication of the study results and will remain accessible for up to 3 years
• Access Criteria: 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.

Locations

PA (1)