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NCT07639073
Low-Dose Versus Conventional-Dose Oral Isotretinoin for Acne Vulgaris
Conditions: Acne Vulgaris
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 164
Sponsor: Pakistan Institute of Medical Sciences
Location: Pakistan Institute of Medical Sciences(PIMS) Islamabad
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07639073). StuddyBuddy aggregates publicly available trial information.