Health TrialsbyHealthPanel

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

ConditionAcne Vulgaris
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPakistan Institute of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Both genders

Age 18-45 years

Patients who are clinically diagnosed with moderate to severe acne vulgaris as per criteria defined in operational definition.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Low Dose Oral IsotretinoinExperimental treatment 1 intervention
Group B: Conventional Dose Oral IsotretinoinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks

Secondary outcomes

1

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

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pakistan Institute of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: