Acne Vulgaris
Conditions
Keywords
Isotretinoin, Accutane, Acne Treatment, Dermatology, Low dose Isotretinoin, Conventional Dose Isotretinoin, Retinoids
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: 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.
Interventions
DRUGIsotretinoin
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.
Sponsors
Pakistan Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Global Acne Grading System(GAGS)Scoring | 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. |
| Percentage change in total acne lesion count from baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | 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. |
Countries
Pakistan
Contacts
CONTACTDr Nareeman Ur Rehman, MBBS, FCPS
PRINCIPAL_INVESTIGATORDr Nareeman Ur Rehman, MBBS, FCPS
Pakistan Institute of Medical Sciences (PIMS)
Outcome results
None listed