Low-Dose Versus Conventional-Dose Oral Isotretinoin for Acne Vulgaris
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Isotretinoin.
- Кому может быть актуально
- Состояния в реестре: Acne Vulgaris. Базовые параметры: 18 лет — 45 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Пакистан
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparing the Efficacy and Safety of Low-Dose Oral Isotretinoin Versus Conventional-Dose in the Treatment of Acne Vulgaris
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Isotretinoin
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.
Первичные конечные точки
- Change from baseline in Global Acne Grading System(GAGS)Scoring [Срок оценки: 12 weeks]
- Percentage change in total acne lesion count from baseline [Срок оценки: 12 weeks]
Вторичные конечные точки (1)
- Incidence and severity of treatment-emergent adverse events (TEAEs) [Срок оценки: 12 weeks]
Критерии участия
Критерии включения
- Both genders
- Age 18-45 years
- Patients who are clinically diagnosed with moderate to severe acne vulgaris as per criteria defined in operational definition.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Пакистан · 1 центр
- Pakistan Institute of Medical Sciences(PIMS) — Islamabad
Идентификаторы
NCT: NCT07639073 · PIMS-DERM-ISO-2026-01